- Sanofi Group (Bridgewater, NJ)
- **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
- BeiGene (San Mateo, CA)
- …industry best practice submission processes. The SD will successfully lead the Global Regulatory Affairs organization in identifying and guiding process ... and values. As the Head of Global Regulatory Operations, the SD will lead key...degree preferred. + Required Experience: Minimum of 12 years Regulatory Affairs and/or Regulatory Operations… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and external regulatory agencies. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy ... Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and...partners, stakeholders, and teams. You will oversee or otherwise lead impact assessments on major global labeling… more
- Google (San Francisco, CA)
- …with governments and regulators while mitigating risk. As Senior Director, Regulatory Affairs , Content Advisory Global Lead , you'll join a Global ... attention to detail with the ability to be action-oriented. Regulatory Affairs helps the company innovate responsibly...and Engineering teams to help ensure compliance. As the Global Lead , you'll oversee teams covering specific… more
- Amgen (Washington, DC)
- … Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is: + To lead GRTs within Amgen's GRAAS organization + To ... Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides...you will lead one or more the Global Regulatory Teams (GRT) in the … more
- ADM (Kennesaw, GA)
- …proactively to anticipate any regulatory change impacting **Required Skills:** + Global Regulatory Affairs experience + Leadership and team management ... - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory Affairs , Corporate Security **Job Description:** ** Global Head...is the strategic regulatory & scientific strategy lead for Global H&W business. + The… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Director, Global Regulatory Affairs , Precision Medicine you will develop and ... will need to work closely with the Vice President, Global Regulatory Affairs Oncology and...and presents to senior leadership as required. + Develops, lead , and communicate a business plan to and implements… more
- Merck (Upper Gwynedd, PA)
- … Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing 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 (Bridgewater, NJ)
- **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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. Global Medical Affairs Lead , Uplizna **Live** **What you will do** Let's do ... will be accountable for the development and execution of global medical affairs strategy for Uplizna. +...Leaders, advocacy groups, patients, payers, vendors) + Familiarity with global regulatory organizations, guidelines, and practices +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Amgen (Thousand Oaks, CA)
- … policy and regulatory intelligence teams. Reporting to the Senior Vice President, Global Regulatory Affairs , this key senior leadership role serves as a ... global regulatory initiatives. The Head of Regulatory Affairs Policy & Intelligence leads a...Clinical Development, and others to align Global Regulatory and R&D policy priorities + Lead … 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
- GE HealthCare (Waukesha, WI)
- …work experience) with 3 years of relevant experience in medical device regulatory affairs OR MR Engineering experience OR Imaging Engineering experience. ... Characteristics** + Advanced degree in scientific, technology or legal disciplines + Regulatory Affairs Certification (RAPS) + Team-oriented and responsive to… more
- AbbVie (North Chicago, IL)
- … and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA ... including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs ...regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory … 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
- Taiho Oncology (Princeton, NJ)
- …to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory ... with the US Food and Drug Administration (FDA). + Lead /support Regulatory subteam(s) for assigned projects to...and other product-related teams. Foster and facilitate communication with Global Regulatory Affairs on these… more
- Merck (Rockville, MD)
- …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