- Takeda Pharmaceuticals (Boston, MA)
- …possible 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 ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Merck (Boston, MA)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Associate Director , Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies ... Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device regulatory strategies and… more
- AbbVie (Waltham, MA)
- …and a promising oncology pipeline. AbbVie is seeking an exceptional Ocular Medical Director / Scientific Director , Medical Affairs (ELAHERE) in Oncology to ... for patients and multidisciplinary medical teams. Responsibilities + The Ocular Medical Director / Scientific Director , Medical Affairs (ELAHERE) will be… more
- AbbVie (Cambridge, MA)
- …understanding of relevant therapeutic area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. + ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Philips (Cambridge, MA)
- …procedures to ensure an effective Quality System is maintained. + Reporting to the Director of Regulatory Affairs -Ultrasound, you will collaborate with ... The Principal Regulatory Affairs Specialist will play a...+ You have a strong understanding of all relevant global regulatory requirements, flexibility and adaptability to… more
- Merck (Boston, MA)
- **Job Description** **Health Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZ** The Health Systems Oncology Medical Affairs ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs , and other members of… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Medical Affairs Director - Evidence Generation, Respiratory **Location:** Cambridge, MA Our Medical function serves as a valued strategic partner ... with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support...improve the lives of patients. We are an innovative global healthcare company with a focus on immunology that… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation where you will ... define, develop and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Actalent (Boston, MA)
- …* Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs and Agency briefing ... the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies that maximize probability of success. * Support the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the best of my knowledge. **Job Description** **Objectives:** + The Associate Director , Global Scientific Communications, Mature Brands, is a dynamic, strategic ... role within Global Medical Affairs that collaborates with cross-functional...planning and execution for mature brands. + The Associate Director , Global Medical Communications is a key… 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 ... for chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** + The Global Medical Director of Rheumatology, reports to the … more
- AbbVie (Cambridge, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more