- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in… more
- Merck & Co. (North Wales, PA)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- 3M (Austin, TX)
- **Job Description:** ** Senior Regulatory Affairs Associate ** **Collaborate with Innovative 3Mers Around the World** Choosing where to start and grow your ... environments to a 3M career.** **The Impact You'll Make in this Role** As a ** Senior Regulatory Affairs Associate ** , you will have the opportunity to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs ...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Lilly (Indianapolis, IN)
- …who are determined to make 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 ...strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous improvement in… more
- Chiesi (Cary, NC)
- …+ Promotional Material/External Communications Responsibilities: + Heads Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... + Prepare Standard Operating Procedures for related activities and provide training to Regulatory Affairs and other departments as appropriate. + Review and… more
- Organon & Co. (Jersey City, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new legislations, guidelines and ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL),...entire life cycle of the drug. + Represent Global Regulatory Affairs within our company's internal committees… more
- United Therapeutics (Albany, NY)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will oversee the development… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- PLUS Communications (Arlington, VA)
- …advertising and media buying. PLUS means more! PLUS Communications is looking for a Public Affairs , Senior Associate to play a key role developing and ... Ideal candidates will have experience distilling complex policy issues and/or regulatory affairs at the federal or state level. Requirements Your day in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and execution of all ... people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination...concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected to… more
- University of Colorado (Aurora, CO)
- **Medical Director of Autopsy Pathology, Medical Director of Decedent Affairs , and Perinatal Pathology Open Rank Assistant, Associate , Professor** ... meet expectations and regulatory requirements. + As Medical Director of Decedent Affairs , you will serve as an information conduit upwards to Vice Chair of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC ... Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications are...regulatory strategies. + Under the guidance of more senior staff, oversees the preparation of CMC regulatory… more
