Drug Registration Manager Stellenangebote

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Stellenangebote Drug Registration Manager Jobs bei Neuvoo

Stellenangebot Drug Registration Manager Job bei Wu Xi App Tec

Job vor 11 Tagen gefunden Wu Xi App Tec

Quality Control Senior Scientist

• 2108 Couvet, NE, Switzerland

MEHR

The Senior Scientist is part of the the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API) , and drug product (Bulk) as well as new technologies at the site. The Senior Scientist provides technical and scientific expertise to support transfer/ verification/ validation of new methods and investigation and troubleshooting of analytical issues (commercial or not) . Additional duties includes participating to registration stability studies, participating to supplier qualification supplier Audit, participating to cleaning validation and validation processes, and leading QC risk assessments. The Senior Scientist assists other technical support team members with questions and technical issues and acts as a point of contact in absence of the Manager. He/ she plays an expert role and shares know- how with colleagues regarding methods, deviation, CAPA, Change control and QC [...]

Stellenangebote Drug Registration Manager Jobs bei Jobleads

Job gestern gefunden Global Regulatory Affairs Lead • Bern Führungs-/ Leitungspositionen

MEHR

[...] product portfolio teams (e. g. , PST, CDT, SMT) . Lead product portfolio GRASTs to ensure timely global regulatory submissions, partnering with Regulatory Project Managers for on- time delivery. Oversee GRA project deliverables (e. g. , Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and support GRAST members as needed. Review and sign off on CTD clinical/ safety documentation for development and registration. Collaborate with GRA regions in global health authority interactions and participate in product- related discussions. Ensure effective communication between product [...] years biotech/ pharmaceutical industry, with 5 years regulatory experience, including 3 years in development. Direct agency interaction experience, preferably ICH regions, as well as exposure across multiple ICH health authorities. Team leadership experience, preferably 3 years as direct or matrix manager. Clinical (or Device/ Combination Product) regulatory experience desired. Exposure to market access activities is desired. Strong scientific and ethical foundation. [...]

Job vor 2 Tagen gefunden

Nursing Manager- Mount Gambier Prison

MEHR

[...] Gambier Prison, Mount Gambier SA, and would require relocation. What G4S can offer you Develop your leadership skills in the complex and unique environment of correctional healthcare Join a supportive Senior Management Team and report directly to the Prison General Manager Explore and implement new approaches to healthcare delivery and how our nurse- led clinic runs Relocation assistance is available About [...] nurse- led clinic onsite, leading a highly dedicated team of 12 Registered Nurses and two Medical Administrators. As the Health Services Manager, youll oversee the delivery of essential healthcare services to prisoners, including physical and mental health triaging, support, and drug and alcohol addiction management. Reporting to the General Manager, this position sits within the Senior Management Team, offering opportunities to [...] Prison Health, to ensure the provision of comprehensive healthcare services. Risk Management: Identify and mitigate health and safety risks within the health centre, ensuring compliance with relevant regulations and standards. What were looking for Registered Nurse with a current AHPRA registration. Proven leadership ability, with experience leading multidisciplinary teams and driving change. Excellent communication and interpersonal skills. Experience working in acute [...]

Job vor 3 Tagen gefunden RBC Manager (d/ f/m temporary contract for 2- years) • Kundl, Tirol

MEHR

Job Description Summary As a member of our Global Regulatory Affairs CMC team, your role would be to provide global CMC regulatory strategic and operational direction and documentation for biosimilar projects and products covering development, registration and approval/ post approval activities. Job Description Sandoz is going through an exciting and transformative period as a global leader [...] role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Job search Sandoz #Sandoz Skills Desired: Clinical Trials, Detail- Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance #J- 18808- Ljbffr 26973522 [...]

Job vor 3 Tagen gefunden

Clinical Development Medical Director- Immunology (All levels)

• Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

[...] needs. Your responsibilities will include: Provide clinical leadership and medical strategic input for deliverables in the assigned project/ program. Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/ registration dossiers, and publications (e. g. , IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) . [...] section of the program in partnership with global line functions, assigned Global Trial Directors (GTDs) , and regional/ country medical associates. Oversee/ conduct medical and scientific review of trial data with Clinical Scientific Expert (s) . May be the Program Manager of other associates (e. g. , CSE) . May function as study medical monitor. Support SR/ GPCH in ensuring overall [...] equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/ scientific area; Clinical practice experience 4 years (including residency) preferred. Fluent oral and written English. Minimum requirement of years of experience in clinical research or drug development will be commensurate with level: Assoc. CDMD 3 years, CDMD 5 years, Snr CDMD 7 years. Working knowledge of [...]

Job vor 11 Tagen gefunden Senior QA/ RA Project Manager • Appenzell Innerrhoden

MEHR

Senior Manager QA Projects Neuch tel, Switzerland Bio Talent is currently supporting a leading global pharmaceutical CDMO organisation that are seeking a [...] site Quality activities and ensure compliance with workplace safety policies and laws. Requirements: Extensive experience in QA, QC and/ or RA in the pharma industry. Regulatory Expertise: Deep understanding of cGMPs and regulatory requirements across Swiss, EU, and FDA jurisdictions. Drug Development Lifecycle: Proven experience in all phases of drug development, including clinical trials, technology transfer, and product launch. Oral Solid Dosage Focus: Strong knowledge of manufacturing, packaging, testing, warehousing, validation, and registration processes for oral solid dosage forms. Strategic Leadership: Demonstrated strategic thinking, business acumen, and ability to translate strategies into tactical [...]

Job vom 30.11.2024

Senior Process Manager (DS Biologics)

• Basel, Basel- Stadt

MEHR

[...] up, execution and documentation of technical studies, qualifications and validations. Contribute during set up of new analytical specifications and stability programs and review changes thereof. Write and review applicable sections of the APR/ PQR. Write and review applicable sections in registration files, variations and market expansion. Support in sourcing evaluation of new DS contract manufacturers and participation in developing supply and [...] Experience/ Work Experience University education in Chemistry, Biology, Biotechnoclogy, Pharmacy or similar. +5 years of experience of development and manufacturing of DS for clinical and commercial use. Skills/ Knowledge/ Languages Scientific and technical background of CMC development and manufacturing of Drug Substance. Recognized expert in drug substance manufacturing Demonstrable experience of working in cross functional team with ability to multi task, [...]

Job vom 16.11.2024 Senior Process Manager MSAT • Basel, Basel- Stadt

MEHR

[...] Opportunities for professional growth Diversity and Inclusion Making a positive impact to help ultra- rare disease patients who are in need of life- saving treatments Job Description The right candidate will manage the following tasks: Subject matter expert (SME) for Drug Substance of small molecule, non- sterile dosage forms. Process owner of Drug Substance small molecule, non- sterile dosage forms validation [...] up, execution and documentation of technical studies, qualifications and validations. Contribute during set up of new analytical specifications and stability programs and review changes thereof. Write and review applicable sections of the APR/ PQR. Write and review applicable sections in registration files, variations and market expansion. Lead and execute MSAT projects such as manufacturing process and cost improvement as part of [...]

Job vom 07.11.2024

Director CMC (Reporting to Vice President CMC IP)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

[...] chemistry, formulations, our internal team of experts and various CDMOs integrated into the pharmaceutical development of our product candidates from preclinical stage to commercial. Key focus of your work will be the new pharmaceutical product application and preparation of commercial drug supply of our proprietary lead product candidate. Responsibilities: Manage Chemistry, Manufacture and Analytical Control of the entire development products from early phase I up to submission for market authorization. Lead the CMC aspects of product development programs and manage the Pharmaceutical Development group. Provide scientific and technical expertise into selection of new drug candidates and development programs. Validation and registration batch generation for drug substance and drug product Process validation and qualification of analytics for Phase 3 product candidate Setup [...] requirements. Experienced in complex project management, negotiations with external partners and Due Diligence processes Audit experience Capacity of effectively organizing and monitoring projects and plans with attention to detail and deadlines to secure progress and goal achievement Persuasive pro- active manager and trustful, reliable person with entrepreneurial spirit, who generates enthusiasm and positive group dynamics Excellent team- oriented leadership and management [...]
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Job vom 07.11.2024 REGULATORY AFFAIRS PROJECT MANAGER • Basel, Basel- Stadt

MEHR

[...] encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description Summary As Regulatory Affairs Project Manager, you will be responsible for managing various projects for Alira Health clients with the support of Senior regulatory experts and subject matter experts within Alira Health. You will have the opportunity to support clients in a broad range of drug development activities from early to late stage of development, to address client issues and to achieve project objectives. We are [...] or pharmaceutical industry. Job Description ESSENTIAL JOB FUNCTIONS Develop and lead regulatory activities for their own projects with support of Alira Senior Director/ SVP if needed e. g. : Provide regulatory strategy advice for entry to human, clinical development or registration. Prepare Health Authorities interaction in collaboration with other functions. Prepare and submit packages for regulatory agencies e. g. EMA, EU [...]

Job vom 07.11.2024

Regulatory Affairs Manager

• Martigny, Wallis

MEHR

[...] registered with the main regulatory authorities. The Company is a world leader in polylactic- co- glycolic acid (PLGA) - based injectable, sustained- release technology. For its Regulatory Affairs Department, Debiopharm Research Manufacturing in Martigny is looking for a REGULATORY AFFAIRS MANAGER, 100 Your Mission : Manage all post- marketing regulatory activities of chemical pharmaceutical drug products including renewals, CMC variations, updates of labeling, and extensions of indications. Your Responsibilities : Maintenance of registration files for all post- approval activities. Author, review, and lead high- quality documents for regulatory submissions. Prepare responses to questions [...]
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Weitere Stellenangebote Drug Registration Manager bei Neuvoo

Stellenangebot Drug Registration Manager Job bei Elanco

Job vor 3 Tagen gefunden Elanco Advisor- R D • Monheim, North Rhine- Westphalia

MEHR

[...] late phase data in support of product development; effectively work within a cross- functional team responsible for the creation, establishment, and delivery of an effective development program; develop and be responsible for the regulatory strategy in support of global product registration, commercialization, and LCM (S E) ; lead discussions with external partners and/ or customers to further refine regulatory strategies; drive submission execution to maintain compliance, meet the reporting requirements for the registration and approval of new animal drug/ veterinary medicinal/ specified feed additive applications, within optimal timelines and achieving business appropriate labels. Provide regulatory and technical overview of [...] global regulatory strategy Participate in/ contribute towards improvements in processes and procedures to deliver regulatory excellence in the new product development space Participate in post approval strategy and delivery globally. Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/ [...]

Stellenangebot Drug Registration Manager Job bei PAION Pharma GmbH

Job vom 29.11.2024 PAION Pharma GmbH

Production Manager Drug Product

• Aachen, North Rhine- Westphalia Work-Life-Balance

MEHR

Marketing . Your tasks The Prodcution Manager Drug Product at PAION ensure the supply of drug product to meet PAIONs commercial requirements from the manufacturing/ production perspective. Establishs, [...] manufacturing process transfer programs Draw up, review and maintain internal and external production- related documents i. e. validation reports, risk assessments, master and executed batch records, as well as SOPs Provide technical support with the drawing up and maintenance of registration documentation General management and control of external vendors as well as the co- ordination of interactions with these vendors in [...]

Stellenangebot Drug Registration Manager Job bei Nuvisan GmbH

Job vom 27.07.2024 Nuvisan GmbH Scientist (f/m/d) in vitro DMPK • Grafing, Bavaria

MEHR

[...] in- depth in vitro ADME expertise. RESPONSIBILITIES Planning, conducting, evaluating, and reporting of the following in vitro ADME experiments in adequate quality and in compliance with delivery timelines: Protein binding CYP inhibition induction Whole blood distribution Microsomal and hepatic clearance Drug transporter investigations Review and interpret analytical data and take responsibility for accuracy and compliance. Leading all aspects of studies to [...] in the preparation of presentations, customer visits and audits Identify issues and provide technical troubleshooting in in vitro ADME experiments Ensure compliance with regulations (e. g. GxP guidelines, radiation protection) in relation to R D processes, study conduct and drug registration Creation of quality- relevant documents such as SOPs QUALIFICATIONS PhD/ post- doc in life sciences (e. g. chemistry, biochemistry, pharmacy) [...] and development Free parking spaces directly on site and a canteen in- house A dynamic, future- oriented, and employee- oriented company, with room for growth and your own ideas Interdisciplinary, agile teams with flat hierarchies Ansprechpartner Stefan Cassier Talent Acquisition Manager Online bewerben Diesen Job teilen Impressum Datenschutzerklärung Powered by softgarden 98019669 [...]
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Stellenangebot Drug Registration Manager Job bei Fresenius Medical Care

Job vom 30.06.2024 Fresenius Medical Care

Registered Dietitian

• Bad Homburg, Hesse Work-Life-Balance

MEHR

[...] control. Adheres to FMCNA algorithm and medical record policies. Reports on nutrition QAI results and participates in the interdisciplinary QAI program. Collaborates and coordinates with team members in provision of Pre- ESRD education as appropriate. When appropriate, works with Case Manager to coordinate plan of care for patient education and identifies candidates to refer to physician for nutritional supplements, as per [...] pertinent staff meetings (, general staff, quality improvement) , Care plan meetings, and others as applicable. Consults with FMS Corporate Dietitian regarding nutrition concerns as needed. Maintains and improves knowledge and skills for a competent and innovative practice. Maintains dietetic registration and continuing education hours as specified by American Dietetic Association and state licensure regulations where applicable. Collaborates with interdisciplinary team, [...] customer service, relationship development, results orientation, team building and decision making. Able to perform responsibilities with minimum supervision. Basic computer skills required. EO/ AA Employer: Minorities/ Females/ Veterans/ Disability/ Sexual Orientation/ Gender Identity Fresenius Medical Care North America maintains a drug- free workplace in accordance with applicable federal and state laws. Career with a purposeWe offer an opportunity to create and [...]
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Stellenangebote Drug Registration Manager Jobs bei Job-Consult

Job vom 16.09.2024 Recruiter Vitaly Pryadka Pharmacist, France • Lorraine/ (Frankreich)

MEHR

[...] pryadka lorraine responsabilits for our client a hospital center we are looking for pharmacists the current team is composed of pharmacists the job profiles we are looking for are oriented on the following sectors pharmacotechnics clinical parmacy computerization of the drug circuit sterilization quality assurance manager other requirements pharmacist meeting the requirements of the decree of january concerning the conditions of exercise in pui registration to the list of aptitude of hospital pharmacists rmunration monthly salary between and net month requirements expectations be a national [...]
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Job vom 28.06.2024 PhD- Jobs. NET

Pharmacist

• France/ (Frankreich)

MEHR

[...] jobs net france for our client a hospital center we are looking for pharmacists the current team is composed of pharmacists the job profiles we are looking for are oriented on the following sectors pharmacotechnics clinical pharmacy computerisation of the drug circuit sterilisation quality assurance manager other requirements pharmacist meeting the requirements of the decree of january concerning the conditions of exercise in pui registration to the list of aptitude of hospital pharmacists remuneration and benefits monthly salary between and net month requirements and expectations [...]

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