Regulatory affairs cmc in Waltham, MA
Regulatory Affairs CMC Officer
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from...
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 Drug Substance/CMC Lead
What if you could join a rapidly growing company and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way? What this position is all...
Director, CMC
Job Description The Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO)...
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...
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...
Regulatory Payments Compliance Director
BlueSnap is a rapid growth international FinTech company, headquartered in Waltham, MA, with offices in Israel, Ireland, and the UK. We are thrilled to be one of the fastest growing companies in the payments industry. Our team works...
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...
Head of Regulatory Affairs
Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early...
Director, GRA CMC Pharmaceuticals, Oligonucleotides
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...
Director, Regulatory CMC
Overview: Be Seen and Heard at EyePoint Pharmaceuticals ...
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 of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonus
Director of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonus Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and...
Regulatory Affairs Manager
Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences is inventing, developing, 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, CMC
Job Description The Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO)...
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...
Scientist, CMC Biological Assay Development
THE COMPANY enGene is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing...
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...
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...
Senior Regulatory Affairs Specialist
Overview: Werfen ...
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...
Environmental Health & Safety Technician (EHS Technician)
As an Environmental Health & Safety Technician you will have the opportunity to provide technical Environmental, Health & Safety (EHS) support for our growing list of life science and high-tech clients. In this role, you will work in conjunction...
Regulatory Affairs Manager
Qualifications: degree or above in a relevant discipline requiredyears of industrial experience in IVD or medical device FDA registrationin Chinese...
Medical Device Quality & Regulatory Project Manager
Great QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this...
Associate Director, CMC Biologics Drug Product 2026530
Location: Newton, MA (Onsite) Science: Monoclonal antibody therapeutics Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and...
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...
Regulatory Affairs Director
Job Description About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and...
Sr. Director, Clinical Regulatory Affairs (Hybrid)
Our client is seeking a Sr. Director, Clinical Regulatory Affairs to develop regulatory strategies for both non-clinical and clinical programs and lead interactions with regulatory authorities. Reporting to the SVP, Head of Regulatory Affairs,...
Senior Specialist/Manager, CMC Quality Assurance
Who we are looking for:Vor Bio is seeking a Senior Specialist/Manager, CMC Quality Assurance who will be responsible for providing Quality support for CMC Operations at Vor's internal manufacturing facility and external manufacturing partners. The...