- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction,… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… more
- BeOne Medicines (Harrisburg, PA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data are identified,… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the coordination and execution ... marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Gilead Sciences, Inc. (Washington, DC)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** The Director , CMC Regulatory Affairs Policy, Advisory and ... role will report directly to the Head of Policy, Advisory and Intelligence/ CMC Regulatory Affairs . **JOB DESCRIPTION** + Serve as critical and recognized,… more
- Merck (North Wales, PA)
- …in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of action ... Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director ,...control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …team and provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and ... and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic...for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC )… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global … more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bristol Myers Squibb (San Diego, CA)
- …information. This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs , Supply Chain, Drug Safety/PV, ... to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an...are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Lilly (San Francisco, CA)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in...across multiple countries + Direct experience in clinical and CMC regulatory sciences + Knowledge of Global… more
- J&J Family of Companies (Raritan, NJ)
- …regulatory strategies are in alignment with product portfolio, regional strategies, CMC - Regulatory Affairs strategy, commercial and market access ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...**We are searching for the best talent for a Director , North America Regulatory Leader (Oncology) to… more
- Bayer (Whippany, NJ)
- …Files, etc.); + Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively collaborate with ... **Email:** hrop_###@bayer.com **Job Segment:** Medical Device, Biomedical Engineering, Compliance, Regulatory Affairs , Product Development, Healthcare, Engineering, Legal,… more
- Amgen (Washington, DC)
- …development through commercial + Collaborate with cross-functional leaders in Quality, Regulatory Affairs , Process Development, Manufacturing, and Supply Chain ... the lives of patients while transforming your career. **Senior Director , Product Quality** **What you will do** Let's do...business imperatives + Provide functional and cross-functional review of regulatory CMC submission content + Serve as… more
Related Job Searches:
Affairs,
CMC,
CMC Director,
CMC Regulatory,
Director,
Director Regulatory Affairs,
Director Regulatory CMC,
Regulatory,
Regulatory Affairs,
Regulatory Director