- Sanofi Group (Cambridge, MA)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs),...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… 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 positioning ... This individual is expected to competently and confidently represent Regulatory Affairs as a key member of...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… 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
- Philips (Cambridge, MA)
- **Principal Regulatory Affairs Specialist, Software (US Hub based)** Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the ... Integration and Insights (CII) business unit._ + _Lead project teams for end-to-end Regulatory Affairs input and deliverables for new product introductions and… 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
- 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
- Orchard Therapeutics (Boston, MA)
- Reporting to: Head of Global Medical Affairs Location: United States, ideally Boston or East Coast Job Summary The Senior Director, Medical Affairs will be a ... in North America (NA). This leader will work in partnership with the broader Global Medical Affairs organization and with cross-functional partners to ensure NA… more
- ConvaTec (Lexington, MA)
- …analyses, and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business ... to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions...your strategic thinking skills Our successful Director/Senior Manager Medical Affairs will be involved in all aspects of Clinical… 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
- Sanofi Group (Cambridge, MA)
- **Our Team:** The Global Regulatory Affairs Device...is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine ... portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory...exciting development pipeline. **Key Responsibilities:** + Serve as Device Regulatory Lead on assigned project teams (early… 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)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively ... manage interactions and communications with trade associations and health authorities on regulatory policy matters. + Lead proactive advocacy efforts for… more
- Sanofi Group (Cambridge, MA)
- **Our Team** : This role reports into the Global Medical Affairs Immunology team that is part of the Medical Affairs Specialty Care organization. Our Medical ... and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's… more
- Sanofi Group (Cambridge, MA)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... works under the direction of the Dermatology and Rheumatology Global Medical Lead . This role will closely...preferred + Experience in pipeline, clinical development and/or medical affairs on a global or regional level… more