We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. Associate / Consultant will also provid...
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 an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with increasing independence ...
We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Experience in leading regu...
Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned p...
The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory asse...
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...
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...
Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. The Associate Director of Regulatory Affairs will be responsible for the development and execution of the regulatory strategy for assigned p...
Works with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups, Information Technology, and other departments as needed. Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Department procedures, as needed. Prepare,...
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...
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Provide regulatory input to product lifecycle planning. Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to. Determine trade...
The Associate Director of Regulatory Affairs will be responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects. The Associate Director Regulatory Affairs will be responsible for oversight of the operational execution of Regulatory submissions fo...
Senior Associate, Regulatory Affairs Specialist. We are seeking a Senior Associate, Regulatory Affairs Specialist to join the RA team at Relay TX. Performing routine regulatory operation functions in collaboration with pharmaceutical and clinical development teams to plan, develop, and compile regul...
Associate Director of Regulatory Affairs. Works proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global regulatory filing strategies for the company's programs across the portfolio. Provi...
The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The Associate Directo...
Reporting to the Senior Director, Regulatory Affairs & Global CMC Lead, the Associate Director, Regulatory Affairs-CMC will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. This role is accountable for the planning ...
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...
Associate Regulatory Affairs Director. Responsible for the regulatory execution and implementation of regulatory strategies in the relevant regulatory jurisdiction. Regulatory Leads via the Regulatory Subteam (RSTs) to deliver on business objectives for assigned products/programs (e. Clinical, Comme...
Associate Director, Regulatory Affairs. Health Authority liaison and key member of project teams, establishes and communicates regulatory strategies for development programs, and coordinates the timelines, generation, and submission of complex regulatory dossiers. Maintains knowledge of regulatory r...
The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio. Partner with representatives of Regulatory Affairs including in-country ...
The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The Associate Director, ...
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...
As a Regulatory Affairs Consultnat you will lead regulatory projects and provide regulatory guidance IVD device manufacturers. Responsibilities Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives Developing FDA Q-subs in collaboration...