Global regulatory affairs in Cambridge, MA
Manager, Global Regulatory Affairs CMC
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s ...
Medical Affairs Director
Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS...
Regulatory Affairs Manager
Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more...
Director, Regulatory Affairs Vaccines CMC
About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted...
Head of Global Medical Affairs
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short...
Regulatory Project Manager
Job Title: Regulatory Project Manager Gabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are...
Guest Arrival Expert
Job Number 24086549 Job Category Rooms & Guest Services Operations Location Boston Marriott Copley Place, 110 Huntington Avenue, Boston, Massachusetts, United States VIEW ON MAP Schedule Full-Time Located...
Regulatory Manager
Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on...
Director Clinical Affairs
Director of Clinical Affairs Walker Cole International are proud to be partnered with a private equity backed Diagnostics Company seeking a Director of Clinical Affairs. This is an...
Director of Regulatory Affairs
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is...
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs - Boston, MA - Permanent Proclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston,...
Regulatory Affairs Specialist
Responsibilities: Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued...
Senior Manager Regulatory Affairs, Strategy
Senior Manager/Associate Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing...
Senior Director, Corporate Legal Affairs
How will your role help us transform hope into reality? The Senior Director, Corporate Legal Affairs will use their understanding of securities law and corporate governance, the biopharmaceutical industry, and...
VP, Regulatory Affairs & Quality
Vigil Neuroscience is the world s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain s immune system.
Director, PV Regulatory
To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be...
Sr. Director, Clinical Regulatory Affairs
Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a...
Sr. Director, Clinical Regulatory Affairs, Auto-Immune 2024363
Location: Waltham, MA (Hybrid) Therapeutic Area: Auto-Immune Job Overview: This role involves developing regulatory strategies, leading interactions with regulatory authorities,...
Director, Regulatory Affairs - US Nationwide Remote
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or...
Regulatory Affairs Manager
Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences is inventing, developing, and...
Validation Maintenance Manager (Hybrid)
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda...
Director, Regulatory Affairs Vaccines CMC
About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted...
Office Assistant (Law Firm)
Title: Office Assistant Location: Downtown Boston - 5x a week on-site Salary: Up to $55k/yr Duration: Direct-hire Required Skills and...
Regulatory Affairs Manager
Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more...
Principal Regulatory Specialist
Duties and Responsibilities: Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities...
Head, Corporate & Legal Affairs Strategic Advisor Reporting to CEO; Innovative CRO Remote RETAINED SEARCH
Head, Corporate & Legal Affairs Strategic Advisor Reporting to CEO; Innovative CRO Remote Retained Search Summary: Cornerstone Search Group has been retained by a...
Associate Director Medical Affairs
Associate Medical Director in Medical Affairs Hybrid - on site part-time Boston, MA PERM - Fulltime PharmD or PhD preferred ** Motivated and ready to take on the Strategy of Medical Affairs...
Finance & Regulatory Reporting Manager
This is a hybrid role and will require an onsite presence at Assembly Row in Somerville 1x/week. The Finance & Regulatory Reporting Manager will be part of an interdisciplinary accounting and reporting team...
Hybrid Regulatory Intern
The Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including: Assist in drafting, organizing, and editing regulatory documents for 510(k)...
Senior Director Regulatory Affairs
RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision...