Senior Regulatory Affairs Specialist

<p></p><p>Global Regulatory Affairs Specialist. Responsible for the day‑to‑day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications. </p><p>Full‑time </p><p>Regulatory Affairs Coordinator. Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA). </p><p>Full‑time </p><p>You will be responsible for developing and executing innovative global regulatory strategies for the global development of candidates. </p><p>Full‑time </p><p>$250,000.00 yearly </p><p>Full‑time </p><p>Executive Director, Regulatory Affairs. Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target genetically instructed disease mechanisms and are working to provide safer, more effective options for patients. </p><p>$160,000.00 yearly </p><p>Full‑time </p><p>Rhythm Pharmaceuticals is seeking an exceptional Global Regulatory Lead who embodies our organizational values and thrives in a dynamic, fast‑paced environment. This rare opportunity offers a chance to lead complex regulatory strategies for innovative therapeutics. </p><p>$248,000.00 yearly </p><p>Full‑time </p><p>Director, Global Regulatory Affairs. Stoke Therapeutics is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary platform, we develop next‑generation therapeutics. </p><p>$177,000.00 yearly </p><p>Full‑time </p><p>$144,400.00 yearly </p><p>Full‑time </p><p>Manager, Regulatory Affairs, CMC. The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental programs. This role includes cross‑functional collaboration across product development, quality, and regulatory functions. </p><p>$186,232.80 yearly </p><p>Full‑time </p><p>Cardiovascular, Renal or Metabolism (CVRM) Regulatory Affairs. Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills to drive regulatory success? </p><p>Full‑time </p><p>Executive Director, Global Regulatory Affairs. Vice President, Regulatory Affairs / Sr. Vice President, Regulatory Affairs. The Executive Director, Global Regulatory Affairs will provide strategic and operational oversight to ensure compliance across multiple therapeutic areas. </p><p>Full‑time </p><p>Director Of Regulatory Affairs. We have an exciting opportunity for a high‑impact Director of Regulatory Affairs to lead global strategy for a priority immunology program in a pivotal late‑stage medicine. This role will coordinate with internal teams and external stakeholders to navigate regulatory pathways. </p><p>Full‑time </p><p>Executive Director, Chemistry, Manufacturing, Control for Biologics. The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics‑CMC) is accountable for managing a team of CMC professionals responsible for scaling production and ensuring regulatory compliance. </p><p>$171,000.00 yearly </p><p>Full‑time </p><p>Associate Director, Regulatory Affairs. Entrada Therapeutics is a clinical‑stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that target disease mechanisms at the genetic level. </p><p>Full‑time </p><p>The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regulations. </p><p>Full‑time </p><p>Location 221 CRESCENT ST STE 103A, Waltham, MA, , United States. </p><p>Full‑time </p><p>Vice President, Regulatory Affairs. This is a newly created full‑time position to continue the development and lead the client’s Regulatory Affairs capabilities. The Vice President of Regulatory Affairs oversees global strategy and ensures timely regulatory submissions. </p><p>$150,000.00 yearly </p><p>Full‑time </p><p>Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities include preparing regulatory dossiers and interacting with regulatory agencies. </p> <p></p> #J-18808-Ljbffr