Pharmaceutical Regulatory Affairs Specialist Stellenangebote

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Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs bei Mindmatch.ai

Neu Job vor 11 Std. gefunden Pharmiweb

Executive Director Clinical Development

Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb VP Clinical Development • Leipzig, SN

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb

VP Clinical Development

• Düsseldorf, NW

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Munich, BY Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Cologne, NW Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb VP Clinical Development • Frankfurt

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Frankfurt Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Hamburg, HH Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Essen, NW Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Leipzig, SN Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb VP Clinical Development • Dortmund, NW

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb Executive Director Clinical Development • Dortmund, NW Führungs-/ Leitungspositionen

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb VP Clinical Development • Berlin, BE

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb VP Clinical Development • Stuttgart, BW

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

Job vom 15.12.2024 Pharmiweb VP Clinical Development • Essen, NW

MEHR

[...] also oversee medical project budgets for the respective project (s) . Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within [...] asset (s) , e. g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/ steering committees, adjudication committees and Safety Data Monitoring boards for your projects. Requirements MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry Successful track record in planning, conduct and publication of Basic Science and/ or Clinical Research Sound medical and scientific [...]

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Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs bei Neuvoo.com

Stellenangebot Pharmaceutical Regulatory Affairs Specialist Job bei Mesa Germany GmbH

Job vom 18.12.2024 Mesa Germany GmbH Quality Management/ Regulatory Affairs Specialist (m/f/d) • Waldems

MEHR

[...] about using our skills to serve a greater purpose. We approach each day with a unique, customer- focused vision to protect the vulnerable and empower every employee to make a real difference. Make your difference in Waldems as Quality Management/ Regulatory Affairs Specialist (m/f/d) The Quality Management/ Regulatory Affairs Specialist is responsible for supporting the quality assurance and regulatory affairs processes within the [...] Excel, Power Point) and quality management systems. Effective verbal and written communication skills. Ability to work collaboratively within a team environment. Demonstrated ability to identify issues, analyze data, and propose solutions. Prior or initial experience in the medical device or pharmaceutical industry with a quality management system and approval procedures (ISO 13485, MDR, 21 CFR, GMP) is a plus. Project Management [...]
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Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs bei JobMESH

Job vom 18.12.2024 Mesa Germany GmbH

Quality Management/ Regulatory Affairs Specialist (m/f/d)

• Hessen

MEHR

[...] about using our skills to serve a greater purpose. We approach each day with a unique, customer- focused vision to protect the vulnerable and empower every employee to make a real difference. Make your difference in Waldems as Quality Management/ Regulatory Affairs Specialist (m/f/d) The Quality Management/ Regulatory Affairs Specialist is responsible for supporting the quality assurance and regulatory affairs processes within the [...] Excel, Power Point) and quality management systems. Effective verbal and written communication skills. Ability to work collaboratively within a team environment. Demonstrated ability to identify issues, analyze data, and propose solutions. Prior or initial experience in the medical device or pharmaceutical industry with a quality management system and approval procedures (ISO 13485, MDR, 21 CFR, GMP) is a plus. Project Management [...]

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Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs bei Stellenanzeigen.de

Job vom 17.12.2024 Mesa Germany GmbH Quality Management/ Regulatory Affairs Specialist (m/f/d) • 65529, Waldems, Deutschland

MEHR

[...] about using our skills to serve a greater purpose. We approach each day with a unique, customer- focused vision to protect the vulnerable and empower every employee to make a real difference. Make your difference in Waldems as Quality Management/ Regulatory Affairs Specialist (m/f/d) The Quality Management/ Regulatory Affairs Specialist is responsible for supporting the quality assurance and regulatory affairs processes within the [...] Excel, Power Point) and quality management systems. Effective verbal and written communication skills. Ability to work collaboratively within a team environment. Demonstrated ability to identify issues, analyze data, and propose solutions. Prior or initial experience in the medical device or pharmaceutical industry with a quality management system and approval procedures (ISO 13485, MDR, 21 CFR, GMP) is a plus. Project Management [...]

Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs bei Jobleads

Job vor 12 Tagen gefunden

Vice President, Regulatory Compliance Product Safety (New York)

Führungs-/ Leitungspositionen

MEHR

[...] an olaplex. com email address. From time to time, OLAPLEX may use an external agency for recruitment purposes; however, neither external agencies nor OLAPLEX will ever request payments in relation to an employment opportunity. About the Role: The Head of Regulatory is responsible for ensuring our products safety and planning for and coordinating the implementation of any changes that might be [...] Responsibilities: Formalize and document OLAPLEXs regulatory compliance and product safety testing program, including policies, procedures, and other related documentation, to ensure evidence adherence to and alignment with global laws, regulations, and industry standards. Proactively report on emerging developments and regulatory affairs via an effective global surveillance program, including the introduction of new legislation that is important to OLAPLEXs strategic decisions. Partner [...] safety guidance for usage/ country/ percentage. Oversee and participate in country registration with distributors and third- party certifiers. Oversee and participate in reviewing, revising, and approving artwork and marketing materials to ensure global regulatory compliance. Lead and develop Regulatory Affairs Specialist and Sr. Manager Product Safety team members. Represent OLAPLEX at various industry trade associations (e. g. , PCPC) to ensure [...] discipline, with 15+ years of progressive experience and 8+ years of progressive leadership experience (PhD preferred) . Relevant regulatory affairs and product safety expertise in the cosmetic (across beauty categories) , OTC, or consumer/ personal health care industries and/ or pharmaceutical industries, with a global vision of the profession. Experience in leading, managing, and developing high- performing teams. Demonstrated experience and [...]
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Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs bei StepStone

Stellenangebot Pharmaceutical Regulatory Affairs Specialist Job bei Dr. Falk Pharma GmbH

Job vor 13 Tagen gefunden Dr. Falk Pharma GmbH Medical Writer (m/f/d) • Freiburg Homeoffice möglich

MEHR

[...] therapeutic practice as well as patient health and well- being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Your main responsibility will be to edit and/ or write regulatory and clinical content and documentation, related to new drugs or clinical trials You will draft and manage regulatory and clinical [...] agencies, to compile and organize information and create paperwork that will be reviewed by government or regulatory agencies, such as the EMA or FDA. In this context, you will also be in close contact and exchange with the relevant internal specialist departments. Other responsibilities include conducting extensive research on medical- related topics to ensure that all content is factual and accurate [...] adeptness in ability to translate into a logical, scientifically balanced compelling medical story for appropriate audience. Preparation, initiation and managing of scientific documents (e. g. Clinical Study Protocols or Clinical Study Reports) and publications Ensuring competent communication and information on pharmaceutical- medical issues internally and externally Cooperation with R D in the preparation and updating of Investigators Brochures Cooperation with Global Safety Collaborate with Regulatory Affairs on clinical summaries and modules for marketing authorisation applications as well as deficiency letters, orphan applications, Addenda to Clinical Overviews [...]
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Job vom 16.12.2024 Formycon AG Master Data Specialist (gn) Supply Chain Logistics • Martinsried/ Planegg Homeoffice möglich

MEHR

[...] of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon [...] governance of master data within the organization. This role ensures the accuracy, consistency, and reliability of data, supporting various functions including research, development, and regulatory compliance. The ideal candidate will possess a strong background in data management, particularly within the pharmaceutical industry, and have a keen eye for detail and process improvement. Lead the development, implementation, and management of master data governance processes. Ensure the accuracy, completeness, and consistency of master data across all systems and databases (including BOM creation and maintenance) . Develop and maintain an artwork- file data base (in close alignment with regulatory affairs) Collaborate with cross- functional teams to define and maintain data standards and policies. Identify and resolve data quality issues and [...] privacy regulations desirable Flexible working time Hybrid work 30 days paid vacation Formycon pension Group accident insurance Formycon card Continuing education offers Team spirit, great working atmosphere and much more . Formycon AG sucht in Martinsried/ Planegg eine/n Master Data Specialist (gn) Supply Chain Logistics (ID- Nummer: 11814530) 26702792 [...]
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