Regulatory Agency Stellenangebote

Neu Job vor 6 Std. bei Jobleads gefunden

Sr./ Principal Statistical Programmer

[...] statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in mentoring others in clinical trial process and CDISC Standards. Excellent written and verbal communication skills. Ability to read, write, speak and understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94 of all Novel FDA Approved Drugs, 95 of EMA Authorized Products and over 200 Studies across 73, 000 Sites and 675, 000+ Trial patients. No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent [...]

Job vor 2 Tagen bei Jobleads gefunden Sr./ Principal Statistical Programmer • Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen [...] experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. [...]

Job vor 6 Tagen bei Jobleads gefunden

Senior Manager, Global Labeling Product Leader (2 Positions)

• Allschwil, Basel- Landschaft Führungs-/ Leitungspositionen Social network you want to login/ join with: Client: Johnson and Johnson Location: Job Category: Other Job Reference: 0511a78861ea Job Views: 4 Posted: 17.04.2025 Expiry[...]

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[...] by peers and manages large projects or processes. This individual will develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations. The Senior Manager, Global Labeling Product Leader will be responsible [...]
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Job vor 6 Tagen bei Jobleads gefunden Senior Manager, Global Labeling Product Leader (2 Positions) • Allschwil, Basel- Landschaft Führungs-/ Leitungspositionen [...] by peers and manages large projects or processes. This individual will develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations. The Senior Manager, Global Labeling Product Leader will be responsible [...]

Job vor 11 Tagen bei Jobleads gefunden

Medical Director (Global Clinical Development) (f/m/d)

• Berlin Führungs-/ Leitungspositionen [...] clinical trials from first-in-human Phase I to Phase III, ensuring compliance, on-time execution, and alignment with corporate goals. Manage clinical study portfolio, ensuring milestones are met and key endpoints, such as ORR and PFS, are achieved. Prepare and participate in regulatory agency interactions for clinical submissions, advice and approvals in Europe and the US. Mentor the clinical operational development team, fostering collaboration [...]
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Job vor 14 Tagen bei Jobleads gefunden Head of Regulatory Affairs-AI P2P (100 remote) • Bern Führungs-/ Leitungspositionen [...] advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance where required. Regulatory Advocacy and Thought Leadership : Leading or participating in regulatory agency interactions and advocacy work regarding legislation relevant to this field. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and [...]
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Job vor 14 Tagen bei Jobleads gefunden

Head of Regulatory Affairs-AI P2P (100 remote)

• Zürich Führungs-/ Leitungspositionen Social network you want to login/ join with: Head of Regulatory Affairs-AI P2P (100 remote) , Zürich Location: Job Category: Legal Services Job Reference: Job[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance where required. Regulatory Advocacy and Thought Leadership : Leading or participating in regulatory agency interactions and advocacy work regarding legislation relevant to this field. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and [...]

Job am 10.04.2025 bei Jobleads gefunden Associate Director, Regulatory Affairs, Marketed Products EUCAN • Zürich Führungs-/ Leitungspositionen [...] Supports Access to Medicines initiatives to develop and implement innovative patient access strategies. Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; companys consultants and Business Partners as required. Proactively builds/ strengthens external stakeholder (Regulatory Agency where applicable, external experts, industry organizations, etc. ) contacts/ influence to achieve Takeda strategic goals and objectives. Oversees and accountable [...]
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Job am 07.04.2025 bei Jobleads gefunden Sr./ Principal Statistical Programmer [...] experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. [...]

Job am 06.04.2025 bei Jobleads gefunden Head of Regulatory Affairs-AI P2P (100 remote) • Zürich Führungs-/ Leitungspositionen Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first stablecoin, USD, but also expanded its horizons into Tether[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance where required. Regulatory Advocacy and Thought Leadership : Leading or participating in regulatory agency interactions and advocacy work regarding legislation relevant to this field. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and [...]

Job am 05.04.2025 bei Jobleads gefunden Head of Regulatory Affairs-AI P2P (100 remote) Führungs-/ Leitungspositionen Head of Regulatory Affairs-AI P2P (100 remote) Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first stablecoin, USD,[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance where required. Regulatory Advocacy and Thought Leadership : Leading or participating in regulatory agency interactions and advocacy work regarding legislation relevant to this field. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and [...]

Job am 03.04.2025 bei Jobleads gefunden Head of Regulatory Affairs (100 remote) Führungs-/ Leitungspositionen Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first stablecoin, USD, but also expanded its horizons into Tether[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance where required. Regulatory Advocacy and Thought Leadership : Leading or participating in regulatory agency interactions and advocacy work regarding legislation relevant to this field. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and [...]

Job am 20.03.2025 bei Jobleads gefunden

HCP Marketing Manager, GSA (Germany, Switzerland, Austria) (Remote/ Flexible)

• München, Bayern [...] work coherently with a wide range of external and internal regional stakeholders like Sales, Medical Affairs, Clinical Training, and Legal. This position will also work closely with International HCP Marketing, International Digital Marketing, Sales Inside Sales, Legal, Clinical Education, Medical, Regulatory agency partners. Responsibilities Maintain an excellent understanding of the insulin pump, CGM, hybrid closed loop market across the region; including motivations [...]
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Job am 02.03.2025 bei Jobleads gefunden Senior Director, Quality • Alzey, Rheinland- Pfalz Führungs-/ Leitungspositionen [...] while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with global regulatory requirements. The Senior Director, Alzey Site Quality Leader, together with the Qualified Person, leads and responds to regulatory agency inspections and inquiries. Key Objectives/ Deliverables: Stay true to Lillys values of Integrity, Excellence, and Respect of People. Make sure [...]
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Job am 18.02.2025 bei Jobleads gefunden

Senior Epidemiologist-Marketed Late Phase Assets (all genders)

• Wuppertal, Nordrhein- Westfalen [...] a Life Sciences degree with a post-graduate qualification in Epidemiology (MSc, MPH or PhD) or a Life Science degree with a PhD in Epidemiology. Several years of Epidemiology and Pharmacoepidemiology experience, including some of that experience in industry or a regulatory agency (e. g. , EMA or FDA) or in a public health/ academic institution with strong links to industry; experience in [...]

Job am 03.02.2025 bei Jobleads gefunden Director of Biostatistics • Boudry, Neuenburg Führungs-/ Leitungspositionen Director of Biostatistics page is loaded Director of Biostatistics Apply locations Princeton-NJ-US, Cambridge-MA-US, Boudry, Seattle-WA Time type: Full time Posted on: Posted 3 Days Ago[...]

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[...] skills. Demonstrate expertise in applying knowledge of general and cutting-edge statistical/ clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards. Experience in preparing and participating in global regulatory agency interactions. Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills. Demonstrate development of approaches to enhance the Workforce Planning and [...]
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Job am 18.01.2025 bei Jobleads gefunden

EHS Manager, H S and Loss Prevention (m/f/d)

• Bonn, Nordrhein- Westfalen [...] equivalent; EHS focus preferred 6+ years of Environmental, Health and Safety (EHS) experience in a manufacturing environment Functional EHS Knowledge in regulatory requirements, EHS technical aspects (machine safety, industrial hygiene, environmental) , risk management, behaviors-based safety, training, auditing/ program review, regulatory agency enforcement, EHS vendor/ consultant management, business knowledge required Proven track record in driving a cultural change in Health Safety with [...]
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Job am 27.12.2024 bei Jobleads gefunden (Senior) In-House Clinical Research Associate (w/m/d) • München, Bayern About us Vertanical is a highly innovative biopharmaceutical company focused on the development of unique cannabis compounds for the treatment of patients with chronic pain.[...]

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[...] review of GCP relevant SOPs. Identify non-compliance trends and systematic risks for assigned areas of responsibility. Support the conduct and follow-up of internal and external audits on Investigator Sites, CROs, supporting laboratories, and monitoring organizations. Support Quality Management by facilitating regulatory agency inspections and related activities. Support of the clinical operations team regarding GCP-relevant questions/ topics. Serve as the primary CQA contact [...]

Job am 22.12.2024 bei Jobleads gefunden

Head of Regulatory Affairs-Tether Evo (Fully Remote, Worldwide)

Führungs-/ Leitungspositionen [...] to ensure the companys readiness for compliance with relevant national and international regulations. There should be a focus on enabling market access for the company in the Brain-Computer Interface (BCI) space. Regulatory Advocacy and Thought Leadership: Leading or participating in regulatory agency interactions. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech, advocating [...]
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Job am 07.11.2024 bei Jobleads gefunden Director Clinical Safety (m/f/x) • München, Bayern Führungs-/ Leitungspositionen Select how often (in days) to receive an alert: Director Clinical Safety (m/f/x) Location: All Europe, Europe, 81379 Passion for Innovation. Compassion for Patients. With[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] global CSPV objectives. Professional experience education: Prerequisite for this position is a successfully completed education as a physician, as well as an approbation as physician. Professional experience of at least four years in a similar position in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required. Oncology product experience is preferred. Work experience with [...]

Job am 07.04.2025 bei Neuvoo gefunden EVIDENT Europe GmbH Quality Assurance Regulatory Affairs Specialist (m/f/d) • Hamburg IT. Headquartered in Tokyo, Japan, Evident employs around 4, 500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs[...]

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[...] an effective interface between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for Evident Business. Provides review, consultation and support for regulatory agency communications for Evident in EMEA Should have a working knowledge of and eager to expand knowledge of the applicable standards [...]

Job am 07.03.2025 bei Neuvoo gefunden Knoell Biologicals Product Development Consultant • Mannheim, Baden- Württemberg Beratungs-/ Consultingtätigkeiten Consulting. Biologicals Product Development Consultant (f m d ) Full or Part Time Europe Experienced Professional August 01, 2023 Hybrid Remote We are looking for[...]

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[...] client documentation intended regulatory submissions to ensure that relevant regulatory/ technical requirements are met. Apply technical, scientific and regulatory knowledge to provide clients with scientifically justifiable, regulatory compliant solutions. Prepare high quality scientific dossiers and documents for regulatory submission. Lead regulatory agency negotiations prior to, and during regulatory procedures to obtain new and maintain existing licenses. Participate in muti-disciplinary product development teams [...]

Job am 07.03.2025 bei Neuvoo gefunden International Flavors Fragrances Site Leader Bomlitz • Bomlitz, Lower Saxony Führungs-/ Leitungspositionen Job Description IFF is a 12B global business producing a multitude of food, pharma, and industrial ingredients used around the world. With over 22, 000[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Ensures regulatory compliance across all core values. Leads identification and prioritization of risk reduction opportunities, establishes clear priorities and supports effective resourcing to drive improvement at the site. (EHS/ PSM, Site security) Leads relationship with local authorities including safety, health regulatory agency, environmental, customs, police. Maintains positive community relations through active participation in local organizations. Accountable for leading and managing the sites [...]

Job am 07.03.2025 bei Neuvoo gefunden ARDAGH GROUP EHS Manager, H S and Loss Prevention (m/f/d) • Bonn, North Rhine- Westphalia Finance. EHS Manager: Health Safety and Loss Prevention for Ardagh Metal Packaging Europe (m/f/d) in any Ardagh Metal plant Role Description: This role is responsible[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] focus preferred 6+ years of Environmental, Health and Safety (EHS) experience in a manufacturing environment and required Functional EHS Knowledge in regulatory requirements, EHS technical aspects (machine safety, industrial hygiene, environmental) , risk management, behaviors-based safety, training, auditing/ program review, regulatory agency enforcement, EHS vendor/ consultant management, business knowledge required Proven track record in driving a cultural change in Health Safety with [...]

Neu Job vor 6 Std. bei NewScientist Jobs gefunden Whoop Lead Clinical Research Scientist • Boston, Massachusetts, United States, Boston Führungs-/ Leitungspositionen WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. WHOOP empowers its members to improve their health and perform[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] requirements. Proven ability to build cross-functional relationships and communicate clearly across technical and non-technical teams. Experience mentoring junior team members and conducting quality checks on clinical and regulatory deliverables. Nice to have: Prior experience working at or closely with a regulatory agency (e. g. , FDA) , or a strong history of successful regulatory interactions. Nice to have: Background in both CRO [...]