- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead , is responsible for ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- AbbVie (Boston, MA)
- …driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ), in the development & execution of the ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada (Oncology) is… more
- Takeda Pharmaceuticals (Boston, MA)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- Sanofi Group (Cambridge, MA)
- …The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… 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 ... of prescription drugs, biologics, and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership and guidance to Commercial teams during the development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …oncology opportunities for either partnering and/or investment. + In collaboration with Global Regulatory Affairs (GRA), monitor and communication with Takeda ... empowered to achieve your best. As part of the Global Oncology Products and Pipeline Strategy team, you will...Identify, monitor and review near-term (within 3 years of regulatory approval) oncology partnering opportunities + Lead … more
- Catalent Pharma Solutions (Chelsea, MA)
- … Regulatory Affairs and regulatory compliance. Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure ... **Associate Director , Regulatory Affairs** **Position Summary:** Catalent is a global , high-growth, public company, and a leading partner for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global regulations to ensure CMC compliance within the organization + Lead regulatory compliance assessment with respect to filing requirements for ... life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you...where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in… more
- Editas Medicine (Cambridge, MA)
- …development and ensure compliance with applicable EMA/FDA/ICH/WHO/ Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions ... trials applications, marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory… more
- Medtronic (Boston, MA)
- …you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team ... Medtronic's Robotic technologies to market. It involves creating, managing and executing global regulatory strategies for new product development as well as… more
- Sanofi Group (Cambridge, MA)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their ... on the TPP, business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Sanofi Group (Cambridge, MA)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist leverages their ... on the TPP, business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Cardinal Health (Boston, MA)
- … experts who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs ... success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory ...bring Cardinal Health to the table, build relationships, and lead the sales process to a close with a… more
- Sanofi Group (Cambridge, MA)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with ... impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director ...and communications with trade associations and health authorities on regulatory policy matters. + Lead proactive advocacy… more
- Takeda Pharmaceuticals (Boston, MA)
- …plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead + Recommend strategies and labeling language for ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that… more
- Novo Nordisk (Lexington, MA)
- …Presidents and other colleagues across global R&D. The Nonclinical Project Director will lead nonclinical project teams. Essential Functions + Manage the ... for clinical trial applications, regulatory interactions, and market registration to global regulatory authorities (eg IB, pre-IND, IND/CTA and NDA/MAA) +… more
- Sanofi Group (Cambridge, MA)
- …dermatologic, respiratory, and gastrointestinal diseases. **Main Responsibilities:** The Global Medical Immunology Pipeline Associate Director , Gastroenterology, ... curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to...direction of the Global Respiratory and Gastroenterology Global Medical Lead This role will closely… more
- Sanofi Group (Cambridge, MA)
- …chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** The Global Medical Director of the Dermatology, Atopic Dermatitis ... function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to...works under the direction of the Dermatology and Rheumatology Global Medical Lead . This role will closely… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Hematology Global Access Strategy and Pricing Director (GASPD) role directly impacts the ability to achieve business objectives on a ... will function with a One Pfizer mindset and will lead a cross functional team of Value and Evidence...strategy and delivery and will collaborate seamlessly across GAV, Global Medical, Regulatory , Commercial, Clinical, Corporate Affairs… more
- Sanofi Group (Cambridge, MA)
- **Sanofi is recruiting a new Global medical Director to support post- regulatory authorization clinical trial program for dupilumab in the Global ... Director will report directly to Medical Evidence Generation Lead , respiratory and will be responsible for phase IV...be an integral part of assisting in building the Global Medical strategy in line with the brand strategy… more