Regulatory cmc in Waltham, MA
Consumer Compliance Senior Internal Audit Associate
Consumer Compliance Senior Internal Audit Associate Boston, United States of America The primary function of the...
Director, Regulatory CMC, Cell & Gene Therapy (Boston)
Job Description General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy...
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...
Regulatory Affairs Specialist
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care,...
Director, Regulatory CMC, Cell Therapy Combination Product (Boston)
Job Description General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) leads a cell therapy combination product program from development through commercialization through the execution of global regulatory CMC...
Regulatory Affairs Manager III
Innova Solutions is immediately hiring for a Regulatory Affairs Manager III Position: Type: Full Time, Contract Duration: 06 Months (Possibility to...
Director, CMC Regulatory Affairs
Job Description Overview: Great Science. Deep Compassion. Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people...
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...
Associate Director, Regulatory Affairs CMC
Company Overview Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates...
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...
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...
IACUC Regulatory Compliance Specialist
GENERAL SUMMARY/ OVERVIEW STATEMENT: The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the...
Manager/Sr. Manager, Regulatory Affairs
Job Description: The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and...
Director, CMC Regulatory Affairs
Site Name: Cambridge 300 Technology Square, GSK House, Stevenage, Upper Merion, USA - Maryland - Rockville, USA - North Carolina - Durham Posted Date: Apr 22 2024 Are you looking for a role where you will serve as a key strategic...
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...
Associate Director/Director, Regulatory CMC
Overview: Be Seen and Heard at EyePoint Pharmaceuticals ...
Quality Regulatory Manager
Job Title: Quality and Regulatory Project Manager Gabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose...
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...
Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)
Become a member of the BioNTech Family! Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies...
Global Regulatory Lead (GRL)
We are currently seeking a Global Regulatory Affairs Lead (GRL) who will be the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofis...
Regulatory Operations Contractor
Recent Pharma/ CRO experience required Regulatory Operations Contractor Regulatory Affairs Location(Boston) Contract Term: Contract...
Mgr Regulatory Affairs
**Mgr Regulatory Affairs - req1193** **OVERVIEW** Responsible for pre-market and post-market activities as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on released...
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...
Consultant Regulatoty CMC
Consultant Regulatory CMC - Permanent - Boston, MA Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This...
Manager/Senior Manager, CMC, Drug Product 2013639
Location: Boston, MA (Hybrid) Therapeutic Areas: Undisclosed Job Overview: Seeking a Manager/Senior Manager CMC to oversee the outsourced process development and cGMP manufacturing...
CMC Process Development Consultant
CMC Process Development Consultant 2023623 Location: Greater Boston, MA (Hybrid) Therapeutic Area: Oncology Job Overview: In this role, the main focus will be on managing CMC processes,...
Director, CMC Quality Assurance
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve...
Lead Consultant, Regulatory Consulting/Life Sciences
Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences &...
Consultant Regulatoty CMC
Consultant Regulatory CMC - Permanent - Boston, MA Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This...