- Nium (San Francisco, CA)
- Your Next Exciting RoleAs the Director of Regulatory Compliance (MLRO), you will be working as part of Nium's global, dynamic Compliance team and will be ... team is responsible for advising the business on all compliance matters and ensuring the regulatory requirements for the US are met. In addition to this,… more
- Adverum Biotechnologies (Redwood City, CA)
- …with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance . The Director /Sr will be responsible for ... The Director /Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key… more
- Luxor Healthcare (Kansas City, MO)
- …operations, including financial management, staff supervision, resident care, and regulatory compliance . Executive Director Responsibilities: Provide ... delivery of high-quality care and services. Maintain positive relationships with regulatory agencies, vendors, and community stakeholders. Executive Director … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director , ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Merck & Co. (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... lead continuous process evaluation/optimization, metric development, collection and monitoring compliance of assigned process with input from Subject Matter Experts,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Takeda (Boston, MA)
- …global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.Ensures ... in order to bring life-changing therapies to patients worldwide.As an Associate Director , Global Regulatory Affairs Marketed Products you will define, develop… more
- Takeda Pharmaceutical (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. ... in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, develop… more
- ClickJobs.io (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. ... in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, develop… more
- Takeda Pharmaceuticals (Boston, MA)
- …global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.Ensures ... in order to bring life-changing therapies to patients worldwide.As an Associate Director , Global Regulatory Affairs Marketed Products you will define, develop… more
- Proclinical Group (Boston, MA)
- Senior Director , Regulatory Affairs - Perm - Boston, MAProclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory ... Responsibilities:The successful candidate will manage the full lifecycle of global regulatory submissions and approvals, ensuring compliance across major… more
- Avidity Biosciences (San Diego, CA)
- …and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.) and regulatory compliance . The position is expected to capably interface with ... Job Title: Associate Director - Regulatory AffairsLocation: San Diego,...organizationAdvise on labeling, promotional review and other post marketing/commercial regulatory activitiesAssure compliance with regulatory … more
- Mannkind Corporation (Boston, MA)
- Position: Executive Director /Vice President, Head of Regulatory Affairs Location: Boston, MA Job Id: 11071 # of Openings: 1 At MannKind our employees are our ... the better. Position Summary: MannKind Corporation is currently seeking an Executive Director /Vice President, Head of Regulatory Affairs. Reporting to MannKind's… more
- Scismic (Boston, MA)
- …that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the company. This ... achieve efficient and timely development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. This role will lead US… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …RA Associate Director , Labelling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating ... The Regulatory Affairs (RA) Associate Director , Labelling...the associated implications on labeling globally, downstream processes, and compliance needs.Participates with influence in or leads departmental and… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob DescriptionAt Gilead, we're creating a healthier world ... Join Gilead and help create possible, together.Job DescriptionThe Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- … regulatory submissions in alignment with corporate goals, and in compliance with all applicable regulatory requirements.Coordinate and collaborate ... in the development and review of standard operating procedures to ensure compliance with current regulatory requirements.Perform all duties in keeping with… more
- Dennis Partners (Boston, MA)
- …innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and ... development and registration of pharmaceuticals.Oversee preparation, review, and submission of regulatory documents, maintaining compliance with regulatory … more
- Avidity Biosciences, Inc. (San Diego, CA)
- Job Title:Associate Director , Regulatory AffairsLocation:San Diego, CA / Hybrid / RemotePosition type:Full timeFLSA:ExemptDepartment: Regulatory and ... and engage with us on LinkedIn and Twitter.The OpportunityReporting to the Director , CMC Regulatory Affairs, the successful candidate will work independently… more
- BridgeBio Pharma (San Francisco, CA)
- Director /Sr. Director , Regulatory Affairs Calcilytix San Francisco, CA/Hybrid Regulatory Affairs Calcilytix Therapeutics, an affiliate of BridgeBio ... individual will manage internal regulatory processes, prepare documents for regulatory submissions in compliance with global health authority regulations,… more
