- 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
- 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)
- …(QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, ... the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive… 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
- J&J Family of Companies (Boston, MA)
- …NA-United States **Organization** Medical Devices & Diagnostics Global Services, LLC (6209) **Job Function** Regulatory Affairs **Req ID:** 2406180116W ... closely with leaders in R&D, Supply Chain, Life Cycle Management, Quality, Regulatory Affairs , Finance, Procurement, Packaging, Marketing, and other business… 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