- Kura Oncology (Boston, MA)
- …all behaviors, decisions, and actions. ESSENTIAL JOB FUNCTIONS: The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and ... providing guidance on US and global regulatory strategies to support development of Kura's oncology and hematology portfolio. The individual must possess excellent… more
- Kura Oncology (Boston, MA)
- …a plus. Collaborates with the cross-functional team comprised of regulatory affairs , clinical development, clinical operations, biostatistics, pharmacology, ... edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical… more
- Zenas BioPharma (Waltham, MA)
- …KOL engagement) Manage cross-functional initiatives with teams like R&D, Commercial, and Regulatory Affairs . Facilitate collaboration between Medical Affairs ... Excellence and Innovation - TRUE Innovation ! Position Summary: The Senior Manager/ Associate Director of Medical Operations will oversee the execution of Medical … more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …to collaborate/support with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs , Biometrics, and Clinical Pharmacology and ... team. What You'll Do: Playing a critical hands-on role within Kailera, the Associate Director, Clinical Quality Assurance will be relied upon as Subject Matter… more
- Wellness Pet Company (Burlington, MA)
- Regulatory Affairs Associate Department: Regulatory Location:Burlington, MA About the Wellness Pet Company The Wellness Pet Company crafts and produces ... difference our products make in the lives of pets. We are currently seeking a Regulatory Affairs Associate to join our team. This person will report to our… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible ... initiatives for your assigned programs. By joining our growing and dynamic regulatory affairs team, you'll be responsible for the effective management and timely… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... could be critical in helping our teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you will contribute:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... prescription medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will… more
- United Therapeutics (Boston, MA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will...Global Regulatory Affairs CMC. **How you will contribute:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... regulatory filings for cellular & gene therapy projects (CAR...be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality… more
- Canon USA & Affiliates (Boston, MA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs , the Regulatory Affairs ... Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry...industry required + Minimum Education Level: 2 Year / Associate 's Degree + 4 Year/ Bachelor's Degree (STEM) preferred… more
- State of Massachusetts (Boston, MA)
- …**Division of Occupational Licensure* **Title:** *Fall 2025: DOL Consumer and Regulatory Affairs Internship* **Location:** *Massachusetts-Boston - 1 Federal St* ... be held both in-person and/or virtually.* *Must be currently enrolled in an associate 's, bachelor's, or a higher degree program. * /**Please submit a cover letter… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary:** The Associate Director of Global Medical Affairs Omnichannel will be responsible for developing and leading the omnichannel strategy for ... Global Medical Affairs across all therapeutic areas and brands. This strategic...all omnichannel activities adhere to internal medical, legal, and regulatory standards. + Collaborate with Compliance and Legal to… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology. ... the development of scientific communications strategy and deliverables, the ** Associate Director, Scientific Communications Lead, Hematology** proactively defines and… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US medical ... and commercial functions. 2. Support development of global and US medical affairs plans in alignment with business objectives. Contribute to commercial strategic… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Applicants pending the completion of ... and the structure and format of a health records. OR Education. An associate 's degree from an accredited college or university recognized by the US Department… more
- Veterans Affairs, Veterans Health Administration (Jamaica Plain, MA)
- …with the Teamlet (Patient, Primary Care Provider, RN Care Manager, Clinical Associate and Clerical Associate ) and expanded Team (family/caregiver, internal and ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more
