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Keywords: Director of Regulatory Affairs, Location: Watertown, MA

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Associate Director, Regulatory Affairs

Job Description The Role: The Associate Director, Regulatory Affairs will join a group of highly motivated, top... pipeline. The Associate Director, Regulatory Affairs provides regulatory support for oncology products in early-stage...

Company: Deciphera
Location: Waltham, MA
Posted Date: 14 Feb 2025

Associate Director, Regulatory Affairs CMC (Onsite Hybrid)

on , , , , and . Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC), you will collaborate... robust relationships across Regulatory Affairs, Operations, and Research & Development (R&D) functions. You will represent...

Company: AbbVie
Location: Waltham, MA
Posted Date: 07 Feb 2025

Associate Director, Regulatory Affairs CMC (Onsite Hybrid)

on , , , , and . Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC), you will collaborate... robust relationships across Regulatory Affairs, Operations, and Research & Development (R&D) functions. You will represent...

Company: AbbVie
Location: Waltham, MA
Posted Date: 06 Feb 2025

Associate Director Regulatory Affairs

to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role... that the outcome is properly communicated to the Organization. Share best practices across the broader Regulatory Affairs...

Company: Alkermes
Location: Waltham, MA
Posted Date: 19 Dec 2024

Senior Director Regulatory Affairs

to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role... Organization. Create a strong regulatory community and share best practices across the broader Regulatory Affairs organization...

Company: Alkermes
Location: Waltham, MA
Posted Date: 18 Dec 2024

Regulatory Affairs Manager

Responsibilities: The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA... candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission...

Posted Date: 29 Nov 2024

Manager, Regulatory Affairs Operations and Project Management

and health authority correspondences. The position will report to the Director, Regulatory Operations and Project Management...Job Description The Manager of Regulatory Operations and Project Management will support the preparation...

Company: Deciphera
Location: Waltham, MA
Posted Date: 14 Feb 2025

Director, Content and Training, Medical Affairs

treatment of NASH with compensated cirrhosis. Role Overview: Director, Content and Training, Medical Affairs The Director... Medical Affairs. The Director will contribute to the Medical Affairs and Scientific Communication Plans that incorporates...

Posted Date: 30 Jan 2025

Associate Director, Pharmacovigilance Operations

, SOPs etc. Collaborate with other departments such as Regulatory Affairs, Quality Assurance, Clinical operations, Data...Job Description Position Summary: Join Deciphera Pharmaceuticals as an Associate Director, Pharmacovigilance...

Company: Deciphera
Location: Waltham, MA
Posted Date: 16 Feb 2025

Director, Supply Chain Operations

treatment of NASH with compensated cirrhosis. Role Overview: Director, Supply Chain Operations... We are looking for an experienced Director, Supply Chain Operations to lead our Supply Chain program management, operations, and strategy initiatives...

Posted Date: 16 Feb 2025

Associate Director, Clinical Data Management

collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables Provide expert... in this evolving industry. We are seeking an Associate Director of CDM to lead clinical data management activities...

Company: Deciphera
Location: Waltham, MA
Posted Date: 15 Feb 2025

Director, Marketing

stakeholders, including but not limited to Medical Affairs, Market Access, Patient Services, Market Research, Sales, Regulatory... Therapeutics commercializes IBSRELA in Canada. Director, HCP Marketing - Biotech/Pharmaceutical (Waltham or Northeast Region...

Company: Ardelyx
Location: Waltham, MA
Posted Date: 15 Feb 2025

Associate Director, Integration Engineer

treatment of NASH with compensated cirrhosis. Role Overview: Associate Director, Integration Engineer As the Associate... Director of Integration Engineering, reporting to the Senior Director of Data and Analytics, you will lead the design...

Posted Date: 02 Feb 2025

Senior Director, Global Marketing

performance in all markets Align with cross-functional teams (R&D, regulatory affairs, sales, and medical affairs) to ensure... research, analytics, medical affairs, regulatory, legal, compliance, field, etc. Lead agency partners, manage budget...

Posted Date: 30 Jan 2025

Director, Translational Medicine

in neurology and psychiatry. The TM Director will have a leadership role in developing and communicating goal-driven, scientific..., pharmacodynamic behavioral endpoints and other translational measures in clinical trials. In addition, the Director will contribute...

Company: Alkermes
Location: Waltham, MA
Posted Date: 19 Jan 2025

Medical Director, Pharmacovigilance

committee meeting to support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs...Job Description We are seeking a Medical Director. This position will report to the Senior Medical Director...

Company: Deciphera
Location: Waltham, MA
Posted Date: 19 Jan 2025

Associate Director/Director Non-Clinical Safety

of development programs Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program...Job Title: Associate Director/Director Non-Clinical Safety (Toxicology) Job Location: United States Job Location...

Company: Lifelancer
Location: Waltham, MA
Posted Date: 17 Jan 2025

Associate Director, Marketing (Nephrology)

Therapeutics commercializes IBSRELA in Canada. Associate Director, Marketing - Biotech/Pharmaceutical (Waltham or Northeast... will report to the Director of Marketing and will contribute and lead key initiatives in support of the US strategic and tactical...

Company: Ardelyx
Location: Waltham, MA
Posted Date: 09 Jan 2025
Salary: $161325 - 197175 per year

Medical Director, Clinical Science

-rare disease patients who are in need of life saving treatments Job Description The Medical Director, Clinical Science... on matters relating to the assigned development program including operational, regulatory and drug safety. Previous experience...

Company: Sobi
Location: Waltham, MA
Posted Date: 17 Dec 2024

Medical Director, Clinical Development (Neurology)

, medical review of clinical trial data and generation of clinical study reports. Additionally, the Sr. Medical Director/Medical... Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global...

Company: Alkermes
Location: Waltham, MA
Posted Date: 29 Nov 2024