- 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
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... the US regulatory post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory … more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director … more
- CSL Plasma (East Providence, RI)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... as or delegates to another appropriate physician the duties of "laboratory director ", "technical consultant", or "clinical consultant" as prescribed by the Clinical… 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
- Merck (Boston, MA)
- …with GCTO ( Global Clinical Trial Operations) country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... **Job Description** With support of Sr CRA/CRA Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager throughout all phases… 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