- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners with the Global Regulatory Lead (GRL) on Global Regulatory ... empower you to shine? Join us as a Senior Director , Global Regulatory Project Management,...you will contribute:** **POSITION ACCOUNTABILITIES:** + Partner with the 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
- Olympus Corporation of the Americas (Westborough, MA)
- … regulatory agencies regarding compliance issues. Directs the development of global regulatory communication processes to include responses to external audits ... and directs regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …**True to Life.** **Job Description** The Endoscopic Solutions Ecosystem Medical Director (ESE) is a physician/surgeon with deep clinical practice knowledge, medical ... the application of prior clinical knowledge and medical training to lead internal stakeholders within the ESE while simultaneously demonstrating proficiencies in… 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
- Manulife (Boston, MA)
- …around the world. From our environmental initiatives to our community investments, we lead with values throughout our business. To help us stand out, we help ... opportunity** Accountable for open and closed-end fund shareholder reports and regulatory filings, including compliance with US GAAP and SEC regulations, managing… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …on developing and implementing efficient, harmonized quality processes compliant with global regulatory requirements. In working with regional (Americas, EMEA, ... by staying **True to Life.** **Job Description** The Executive Director of Quality Process Improvement - Distribution will be...for the distribution value stream and serve as the Global Process Owner (GPO) for the Product Ship Hold… 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