- Sanofi Group (Cambridge, MA)
- **Job title: Global Regulatory Affairs Lead ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs ... relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global ), in early and… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for...possible. Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs (US RA… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on...prescription drugs, biologics, and devices. We are an innovative global healthcare company with one purpose: to chase the… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs , Marketed Products in Cambridge, MA ... and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery of detailed and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or … more
- Merck (Boston, MA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and ... programs in various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, clinical… more
- Editas Medicine (Cambridge, MA)
- …for our programs in clinical development. You will collaborate closely with the global regulatory lead and cross-functional teams to navigate complex ... equitable future. Position Summary As the Senior Manager of Regulatory Affairs , you will play a critical...preferred. + Regulatory Strategy Development: Support the regulatory lead in the creation and implementation… more
- Pfizer (Andover, MA)
- …(CMC) regulatory strategies for small and/or large molecules to meet global regulatory requirements throughout the life cycle. You will participate in ... of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other...global internal partners, ie, Research and Development, Pfizer Global Supply, Global Regulatory Sciences,… more
- Merck (Boston, MA)
- **Job Description** ** Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director of Medical Affairs (GDMA) for ... Thoracic Malignancies coordinates the development of the Global Scientific and Medical Affairs Plans for...organizations, academic or regulatory working teams **Asset Regulatory Management** + Successfully collaborate and lead … more
- Philips (Cambridge, MA)
- …for innovative solutions in all target markets. **Your role:** + _Plan, generate, and lead global regulatory strategy for wearable devices, Software as a ... Intelligence (US Hub Based)** The Principal Regulatory Affairs Specialist- SW & AI will shape, lead...globally. You will work closely with various stakeholders from global Philips Innovation Hubs, and regulatory leaders… more
- Danaher Corporation (Marlborough, MA)
- …expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs CMC Officer for Cytiva is responsible for leading CMC ... internal and partner programs. This position is part of Global Regulatory Compliance in Marlborough and will...from discovery to delivery. What you will do: + Lead development and execution of regulatory Chemistry,… more
- ICP Group (Andover, MA)
- …Pacific region. ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all product-related ... are conducted in accordance with the current domestic and global regulatory statutes that govern the respective...and goals (utilizing subject matter experts and consultants). + Lead the development and coordination of a standardized Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …in medical affairs and Neuroscience.** **Experience successfully leading global cross-functional teams.** **Demonstrated ability to create, lead , and ... **Leads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications… more
- Merck (Boston, MA)
- …in key health systems accounts + Serves as a resource for the HSO MAD Team Lead , HSO Executive Director Medical Affairs , and other members of Country Medical ... **Job Description** Our Medical Affairs team advances patient care by engaging in...in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also… more
- AbbVie (Boston, MA)
- …products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development & ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for… more
- Pfizer (Cambridge, MA)
- …in Inflammation and Immunology specific therapeutic areas + Demonstrated ability to develop, lead and execute global medical affairs strategies and tactics, ... effectively benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead...Medical Director - Abrocitinib Team Lead will lead a team of medical affairs colleagues… more
- Pfizer (Cambridge, MA)
- The Global Clinical Lead is a leadership role that represents clinical development on the Medicine Team as the single point of accountability for clinical ... assets for heart failure and other cardiovascular indications. + Leads the Global Clinical Team towards the common goal of approvable worldwide regulatory… more
- Editas Medicine (Cambridge, MA)
- …will be responsible for: + Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements ... ensure compliance with applicable EMA/FDA/ICH/WHO/ Global regulations and regulatory guidance and guidelines. + Lead CMC...with a minimum of 10 years' experience in drug development/ regulatory affairs and a minimum 8 years… more
- Sanofi Group (Cambridge, MA)
- …input on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic ... study team meetings) + May serve as a regional/local regulatory lead and point of contact with...pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global… more