- Merck (Boston, MA)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MD or Ph.D./Pharm D… more
- Danaher Corporation (Boston, MA)
- …and alignment across global and culturally diverse stakeholders. + Experience with drug development and drug regulatory procedures. Leica Biosystems, ... a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion...of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device… more
- Pfizer (Cambridge, MA)
- …Regulatory and Cross-functional teams, managing submissions, and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19). ... local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your… more
- Takeda Pharmaceuticals (Boston, MA)
- …meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and ... post-market support. + Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. + Able to deal… more
- Rhythm Pharmaceuticals (Boston, MA)
- …+ BS or graduate degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and product registration activities within the ... to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development… more
- Actalent (Boston, MA)
- …US and EU drug and biologic regulations and guidelines including ICH, FDA , and EMA guidelines. + Ability to effectively organize and prioritize tasks to achieve ... Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a… more
- Sanofi Group (Cambridge, MA)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in… more
- Wolters Kluwer (Waltham, MA)
- …metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug ... **Lead Technology Product Manager** - Commercial Drug Information This role follows a hybrid model,...drug clinical attributes, pricing and reimbursement data, and regulatory classifications-and how these data types are used in… more
- Sanofi Group (Framingham, MA)
- …cGMP, ICH, FDA , and EMA regulations + Strong background in Drug Product manufacturing regulations and guidance + Proven experience in Chemistry Manufacturing ... **Team Lead Quality Drug Product Operations** **Location:** Framingham, MA **About the...etc.), quality agreements, and audits + Knowledgeable on current regulatory guidance or requirements (ie, ICH Q9, Annex 3,… more