- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for ... reviewing the CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory … more
- Merck & Co. (Montgomery County, PA)
- …described in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC data or… more
- Insmed Incorporated (San Diego, CA)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , EDC Programming will lead and oversee EDC programming, and ... closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.What You'll Do: EDC System… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: ... execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- CoxHealth (Lake Spring, MO)
- …service agreement terms and conditions. This position will also assist the Regulatory Affairs department with annual contract evaluations. The Contracted ... Equipment Services Director . * Job Requirements ◦ Education ▪ Required: Associate or related Degree in business or Bachelor's degree in business, accounting,… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs , Chemistry, ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research &… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be ... and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties + Act as the Global… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs ** , works ... team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making to help transform the… more
- Sumitomo Pharma (Lincoln, NE)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... in the pharmaceutical industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be managing a significant number of generic… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising ... + Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory , Legal and Public Affairs counterparts. Identifies areas of… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible for ... regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by proactively identifying and managing regulatory /quality risks and opportunities… more
