- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Lead , GI & Inflammation where ... you will define, develop, and lead global strategies to maximize global regulatory...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Merck (Boston, MA)
- …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory...submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... develop and lead global strategies to maximize global ...reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , Global Regulatory Affairs in Cambridge, MA with the ... the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead...Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and meetings with … more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a US Lead , Global Regulatory Policy and Innovation where you will anticipate, ... will also serve as US expert and subject matter lead for regulatory policy and advocacy activities,... & Policy Innovation, you will report to Executive Director & US Head, Global Regulatory… more
- Merck (Boston, MA)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary,...targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Merck (Boston, MA)
- …Description of Position-** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... Japan, Australia and Brazil + Stay abreast of evolving global regulatory landscapes for medical device and...analysis of data for management review. **Reports to** - Director Regulatory Compliance, Device Quality and … more
- Charles River Laboratories (Boston, MA)
- …Boston, MA, San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance** , you will lead regulatory and compliance ... that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance** to join our **Insourcing… more
- Merck (Boston, MA)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... **Job Description** The Executive Director , Device Quality & Regulatory will... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …evidence generation needs; + Collaborates with cross-functional team members to define global evidentiary needs of key stakeholders ( Regulatory bodies, HCPs, ... of peri -and post-approval interventional and RWE prospective study design within Global Medical Evidence (GME) to support access needs. + Provides innovative… more
- Sanofi Group (Cambridge, MA)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... Immunology pipeline assets. The Medical Director will report directly to Global Medical Evidence Generation Lead , Next-Gen Immunology Franchise and will be… more
- Black & Veatch (Burlington, MA)
- …diverse talents and perspectives to use. **The Opportunity** The ** Global Benefits Director ** will have the opportunity to: + Lead the strategic design, ... ** Global Benefits Director ** Date: Oct 22,...plans, administrators, consultants and systems and create recommendations to lead the organization to one unified global … more
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Solid Tumors** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more