- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to… 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 ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating… more
- Genmab (NJ)
- …you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and...Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director ... assigned therapeutic area portfolio. **Responsibilities** The Associate Director will be responsible to: + Develop regulatory...and regulatory single point-of-contact for products within Global Regulatory Affairs and outside.… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible for ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Takeda Pharmaceuticals (Boston, MA)
- …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 Advertising and Promotion lead you will… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** ... possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Boston, MA)
- …Payer Marketing and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global ... Market Access, Pricing, Advocacy, Biostatistics, Global Evidence and Outcomes, Medical Affairs , Clinical Science, Legal, Regulatory + OBU 10, EUCAN, GEM… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... contributes to special projects that advance the capabilities of Regulatory Affairs . + Trains other RA...of current global and regional trends in regulatory affairs and is able to apply… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As the ** Associate Director , Quality Assurance - Global Product Distribution ... + Serve as a key member of the QA Global Supply Chain team who are collectively responsible for...Warehouse, Customer Service personnel as well as Trade Operations, Regulatory Affairs and Validation/Packaging Engineering. + Interfaces… more
- Boehringer Ingelheim (St. Joseph, MO)
- …meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs ( RA ) core or subteam member in projects as well ... **Description** Manager The Manager, Regulatory Affairs ( RA ) Pharma...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for leading RA team members involved in device project ... development and coaching to support cultural change and position RA team as solution providers. + Own regulatory...preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or… more
