Director of Regulatory Affairs CMC

About the RoleGilead Sciences, Inc. is a biopharmaceutical company dedicated to creating a healthier world for all people. As a Senior Manager, Regulatory Affairs CMC, you will play a critical role in providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.Key...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Director, Global Regulatory Affairs, Development StrategyProclinical Staffing is seeking a seasoned professional to fill the role of Director, Global Regulatory Affairs, Development Strategy for a leading global biotechnology company.Key Responsibilities:Develop and implement a comprehensive US regulatory development strategy to ensure successful...

A company is looking for a Director of Regulatory Affairs, Lifecycle. Key Responsibilities Oversee the Lifecycle Regulatory team and manage personnel activities Develop and execute global regulatory strategies for commercialized products Ensure compliance with regulatory Conditions of Approval and oversee advertising and promotion reviews Required...

The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

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Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...

EMPLOYER: AstraZeneca Pharmaceuticals LPTITLE: Associate Regulatory Affairs DirectorLOCATION: Gaithersburg, MDHOURS: Full-Time; Mon-Fri (40 hours/week)DUTIES: Lead the end-to-end planning, coordination, and execution of assigned deliverables. Contribute to regulatory submission strategy, identifying submission risks and opportunities. Lead regulatory...

What You Need to Know About Regulatory Affairs SpecialistExample of Regulatory Affairs Specialist Job: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.Regulatory Affairs Specialist Responsibilities ...

Job Title: Sr. Regulatory Affairs SpecialistTeleflex is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our Global Operations organization, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...

Job Title: Regulatory Affairs AssociateAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.We are seeking a highly motivated individual to provide support to global regulatory activities in obtaining worldwide approvals to...

Job Title: VP, Quality & Regulatory AffairsStratasys is seeking a highly experienced and skilled VP, Quality & Regulatory Affairs to lead all aspects of quality assurance and regulatory compliance across the Global Enterprise.Key Responsibilities:Develop and implement a comprehensive quality strategy that aligns with the company's goals and...

Job Title: Head of Global Labelling - Regulatory Affairs Job Type: Full time permanent position Locations: UK, France, Germany, Ireland, Netherlands, Norway, and the United States of America (Remote) Remuneration: Competitive salary and benefits packageWorking for one of the industry's leading pharmaceutical companies, this is a fantastic opportunity to...

Job Title: Sr. Manager, Regulatory AffairsThermo Fisher Scientific is seeking a highly experienced Sr. Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies for product approvals and compliance in the US and Canada.Key...

The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

About HologicHologic Inc. is a leading multi-billion-dollar public company committed to improving and saving lives through the development and deployment of innovative medical technologies. With a global presence, Hologic specializes in diagnostics, medical imaging systems, and surgical products, providing solutions that enhance the health and well-being of...

Job Title: Regulatory Affairs AnalystAt Air Movement and Control Association International, we are seeking a highly skilled Regulatory Affairs Analyst to join our team. As a key member of our advocacy services, you will play a critical role in analyzing proposed and final regulations, bills, and codes/standards changes.Responsibilities:Prepare advocacy...

The Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), is empowered to provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and (potentially) develop a team of US and/or global regulatory leaders (as...

A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy. Key Responsibilities Develop and execute U.S. regulatory advocacy strategies and action plans Monitor and analyze U.S. regulatory guidelines, regulations, and policies related to medical devices Lead the preparation of document packages for regulatory...