The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for one or more programs. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the st...
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 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...
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, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...
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...
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...
As AD/Director of Regulatory Sciences, you will play a crucial role in effectively operationalizing regulatory strategies, managing regulatory projects, providing leadership, and guiding our company through complex regulatory landscapes. Experience in managing regulatory inspections, audits, and int...
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...
Regulatory Affairs Leader (Associate Director). Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions. Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the ...
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...
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...
The Associate Director will report into the Regulatory CMC group devoted to developing regulatory CMC strategies that support rapid development of products targeting rare and ultra-rare indications. Working knowledge in the rare disease space and the ability to deal with issues of critical importanc...
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, 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...
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...
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 Lexingt...
As the Associate Analyst, you'll be a key member of the US Policy & Regulatory Strategy team that develops policy and regulatory positions to support a reliable, affordable, and decarbonized energy future for our electric and gas customers in the Northeast US. ...
Track regulatory project status and informational documents. Interfacing with global regulatory partners and internal cross functional teams. Minimum of 3-6 years Regulatory Affairs experience required; biologics experience required. Clear understanding of content and organization of regulatory subm...
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, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...
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...