- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … more
- 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
- Genmab (NJ)
- … policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr . Director, Labeling, Policy and ... 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution ... in alignment with overall business objectives. Relationships Reports to the Sr . Director, Wegovy Consumer Marketing . C ollaborates with sales, marketing,… 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. (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
- 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
- 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
- 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
- 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
- Merck (Upper Gwynedd, PA)
- … issues to GRACS CMC management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... **Job Description** GRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … 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
- 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
- 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
- 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
- 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
- Boehringer Ingelheim (Ridgefield, CT)
- …DO, Ph.D., Master's) preferred + Specialized Pharmacist or Master of Drug Regulatory Affairs , RAC certification preferred ** Associate Director Experience ... Group RA, US RRL role will provide experienced US regulatory strategic input to the global and US cross-functional...Director role and between $170,000 and $269,000 for the SR Associate Director role. The position may… more
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