Jobs: cmc group

Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC Department: Regulatory Affairs FLSA Exempt CORE VALUES Respect ? Passion ? Teamwork ? Integrity ? Honesty ? Commitment ? Collaboration ROLE SUMMARY In this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items to ensure regulatory compliance of...

Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC Department: Regulatory Affairs FLSA Exempt CORE VALUES Respect Passion Teamwork Integrity Honesty Commitment Collaboration ROLE SUMMARY In this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items to ensure regulatory compliance of our...

Consultant Regulatory CMC- Permanent - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA.Primary Responsibilities:The successful candidate will provide lifecycle management support to a broad, global...

Consultant Regulatory CMC- Permanent Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in...

Job Description: Title: Regulatory Affairs CMC Location: Foster City, CA Specific Job Responsibilities: Participates in preparing moderately complex CMC regulatory submissions under direction of a senior Regulatory Affairs professional which require some interactions with other members in the Regulatory CMC department and technical teams as well as senior...

PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) Knowledge of...

PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) Knowledge of...

BS/BA degree in Scientific Discipline with 3 years in the pharmaceutical industry, preferably with 1 year CMC regulatory experience Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages,...

They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC, you will work closely with cross-functional teams, CMOs, and Health Authorities. This company...

Senior Director, Regulatory Affairs CMC Hybrid - Philadelphia, PA Meet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (small molecule) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting...

Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (small molecule) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting...

Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (small molecule) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting...

Senior Director, Regulatory Affairs CMC Hybrid - Philadelphia, PA Meet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (small molecule) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be...

Senior Director, Regulatory Affairs CMC Hybrid - Philadelphia, PA Meet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (small molecule) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

Head of CMC Regulatory Affairs Small Molecules United States - California - Foster City Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.Head of CMC Regulatory Affairs - Small Molecules KEY RESPONSIBILITIES The Head of CMC Regulatory Affairs -...

Head of CMC Regulatory Affairs Small Molecules United States - California - Foster City Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.Head of CMC Regulatory Affairs - Small Molecules KEY RESPONSIBILITIES The Head of CMC Regulatory Affairs -...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

CMC Leader, Process and Product Design , Seattle WA /Redmond WA Just-Evotec Biologics is seeking a CMC Leader to support our mission of advancing low-cost biotherapeutics manufacturing to provide access to all. The position sits in the Process and Product Design Group and leads cross functional CMC development teams for commercial process development of...