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Keywords: Director, Regulatory Affairs Strategy, Location: Waltham, MA

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Director, Regulatory Affairs Strategy

an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director... that experience to impact program teams beyond regulatory strategy. This role reports to the Executive Director, Regulatory Strategy...

Company: Alkermes
Location: Waltham, MA
Posted Date: 06 Sep 2025

Director, Regulatory Affairs, Labeling

President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead... regulatory labeling or related strategy to successful conclusion for one or more products. Significant experience working...

Company: Alkermes
Location: Waltham, MA
Posted Date: 04 Sep 2025

Senior Manager/Associate Director, Regulatory Strategy

and diverse backgrounds are connected. The Sr. Manager/Associate Director, Regulatory Strategy, will be responsible for day... reports to the Senior Director, Regulatory Strategy and will be based in Watertown, MA, with the option of a hybrid work...

Posted Date: 09 Aug 2025
Salary: $142000 - 190000 per year

Senior Manager, Regional Regulatory Lead - US (Vaccines)

) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring... strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric...

Company: CSL
Location: Waltham, MA
Posted Date: 21 Sep 2025

Senior Manager, Regional Regulatory Lead - US (Vaccines)

) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring... strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric...

Company: CSL
Location: Waltham, MA
Posted Date: 21 Sep 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: 03 Oct 2025

Group Director, Clinical Pharmacology & Quantitative Pharmacology, Oncology

and Regulatory affairs Scientific and strategic input into pre-clinical, clinical, and post-approval development plans across TA...Job Title: Group Director, Clinical Pharmacology & Quantitative Pharmacology Location: Boston, MA Introduction...

Company: AstraZeneca
Location: Waltham, MA
Posted Date: 26 Sep 2025

Associate Director, Patient-Centered Outcomes Research (Oncology)

members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs... & Operations, Regulatory, Commercial). The Associate Director, Patient-Centered Outcomes Research, will support multiple programs...

Company: AbbVie
Location: Waltham, MA
Posted Date: 18 Sep 2025

Associate Director, Patient-Centered Outcomes Research (Oncology)

members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs... & Operations, Regulatory, Commercial). The Associate Director, Patient-Centered Outcomes Research, will support multiple programs...

Company: AbbVie
Location: Waltham, MA
Posted Date: 18 Sep 2025

Director, US HCP Immunology Marketing

HCPs to inform brand strategy and franchise planning Cross-Functional Leadership Partner closely with the Director...-rare disease patients who are in need of life saving treatments Job Description Sobi is seeking a Director, US HCP...

Company: Sobi
Location: Waltham, MA
Posted Date: 17 Sep 2025

Director, US HCP Immunology Marketing

HCPs to inform brand strategy and franchise planning Cross-Functional Leadership Partner closely with the Director...-rare disease patients who are in need of life saving treatments Job Description Sobi is seeking a Director, US HCP...

Company: Sobi
Location: Waltham, MA
Posted Date: 16 Sep 2025

AD / Director, Global Medical Reviewer

, reporting to Executive Director, Regulatory Affairs, you will positively impact patients’ lives by: Serve as Medical Reviewer...Role Overview & Key Functions:: The AD / Director, Global Medical Reviewer is responsible for the development...

Posted Date: 07 Sep 2025

Senior Director, Marketing – Alixorexton

Job Category: Commercial Degree Level: Bachelor's Degree Job Description: We are seeking a Senior Director... strategy and execution for a transformative, late-stage neuroscience asset during its most pivotal phase: the path to launch...

Company: Alkermes
Location: Waltham, MA
Posted Date: 07 Sep 2025

Medical Director, Clinical Development (Neurology)

and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future... therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations...

Company: Alkermes
Location: Waltham, MA
Posted Date: 29 Aug 2025

Director, Clinical Supply Chain

Job Description We are seeking a Director in Clinical Supply Chain to be part of our Supply Chain team... supply of material. The successful candidate will work closely with Clinical Operations, Quality Assurance, Regulatory...

Company: Deciphera
Location: Waltham, MA
Posted Date: 27 Aug 2025

Director, Market Development

commercializes IBSRELA in Canada. Position Summary: Ardelyx is looking for a Director, Market Development to join a growing fast.... The ideal candidate brings deep experience in market development, access and reimbursement strategy, and strategic...

Company: Ardelyx
Location: Waltham, MA
Posted Date: 20 Aug 2025

Associate Director, Scientific Communication

within Medical Affairs, the Associate Director, Scientific Communications will provide medical, scientific and technical expertise... to others external to Medical Affairs Partner with Medical Directors to develop and implement product specific strategy and alignment...

Company: Alkermes
Location: Waltham, MA
Posted Date: 13 Aug 2025

Associate Director, Addiction Marketing

and other digital channels Manage approval process for digital marketing tactics with Medical Affairs, Legal and Regulatory, including... options available to assist in their recovery journey. Alkermes is looking for an Associate Director of Digital Marketing...

Company: Alkermes
Location: Waltham, MA
Posted Date: 24 Jul 2025

Medical Director II

, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities... and regulatory requirements, Client’s customers, markets, business operations, and emerging issues. Oversees project-related...

Posted Date: 03 Oct 2025

Director, Program Management Office

across our organization including areas such as research, pre-clinical, clinical, pharmaceutical development, regulatory affairs, medical... affairs, commercial, operations, policy and government affairs, patient engagement and corporate communications, as well...

Company: Alkermes
Location: Waltham, MA
Posted Date: 26 Jul 2025