Regulatory Affairs Associate: Average Salary in Framingham, MA in 2024

Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC. The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for exe...

Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. Can apply and adapt this understanding to projects to enhance probability of regula...

Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...

Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...

Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current r...

Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC. Associate Director, Regulatory Affairs CMC. The Associate Director, Regulatory Chemistry Manufactur...

The call to action to extend and improve the lives of cancer patients is louder than ever before, and Syndax is seeking individuals who are committed to science, innovation, and excellence to join us on this mission.With offices in Waltham and NYC and experts employed around the world, you will have...

Regulatory Affairs Leader (Associate Director). Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience. The Regulator...

Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. Can apply and adapt this understanding to projects to enhance probability of regula...

The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...

Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. Can apply and adapt this understanding to projects to enhance probability of regula...

Collaborates with other functional work teams , Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projec...

Minimum of 3-6 years Regulatory Affairs experience required; biologics experience required. Track regulatory project status and informational documents. Interfacing with global regulatory partners and internal cross functional teams. Clear understanding of content and organization of regulatory subm...

Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC. The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for exe...

The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office. The Manager/Senior Manager will also participate to formulate regulatory CMC strategies for product developmen...

Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset. Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strate...

The Program Manager is responsible for key departmental functions related to the compliance programs for Medicaid products. The Program Manager will be expected to proactively identify program or operational process conflicts and compliance / operations integration issues, and recommend prioritized ...

The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC's Portland & Gardner site...

The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. Conceive of and Implement the Regulatory Strategy in ...

Job Title: Construction Project Manager. What Does an Project Manager with Paul Davis Do?. As a Project Manager, you will work with property owners and subcontractors after traumatic events such as fires or floods to restore both residential and commercial properties. Celebrate the completion of pro...

The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collabo...

Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lex...

The Associate Director, Global Regulatory Science CMC Therapeutics Programs, will be responsible for leading regulatory CMC strategy and support for products in clinical development (IND, CTA) and commercial product registrations (BLA, MAA), including, post-approval variations. The Associate Direct...

Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...

Principal Regulatory Affairs Specialist - EndoscopyAbout the role:At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new busine...