- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management and Strategic Planning, ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory...changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues… more
- Takeda Pharmaceuticals (Boston, MA)
- … requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada ... products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ), in the development &… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs ( RA ) serves as the regulatory lead on relative Review Committees (RCs), for products ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… more
- Sanofi Group (Cambridge, MA)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned,… more
- Merck (Boston, MA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Novo Nordisk (Lexington, MA)
- …of any required documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and ... Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo...working relationships with other personnel in Regulatory Affairs and other local and headquarter… more
- Sanofi Group (Cambridge, MA)
- **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and ... products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within … more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating pre-clinical and translational work… more
- Sanofi Group (Cambridge, MA)
- …compound, protocol + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs + CROs + Regulatory affairs + Collaborates with other CRDs ... **Clinical Research Director - allergy-immunology-dermatology** The Clinical Research Director...clinical study report + Take on as necessary the Associate CRD role: + Develop the abbreviated protocol +… more
- Fresenius Medical Center (Waltham, MA)
- …on projects with other FME departments including Compliance, Regulatory Affairs , Clinical Services, the Medical Office, Global IP, and others. ... manufacturers, and related entities. Under the general supervision of an Associate General Counsel or his/her designee, the Fellow undertakes projects supporting… more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Medical Writer...personnel. Relationships The Medical Writer (MW) reports to an Associate Director of Medical Writing. The MW… more