Senior Director, Regulatory Affairs CMC
2 weeks ago
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 into the VP of Regulatory Affairs.
Key Responsibilities
- Manage the process of maintaining and updating CMC sections of assigned regulatory submissions
- Identify and evaluate CMC issues related with new product development including product and process development, analytical methods, and manufacturing
- Manage cross-functional product teams for CMC-related projects, serving as a SME and group leader
Key Qualifications
- 10+ years of industry experience, 6+ specifically in Regulatory CMC
- Experience working throughout all phases of development (IND/IMPD through NDA/MAA)
- Small molecule background highly preferred
Please reach out to Ryan Moran to learn more about this position:
ryan.moran@peoplewithchemistry.com
by Jobble
#J-18808-Ljbffr-
Senior Director, Regulatory Affairs CMC
15 hours ago
Philadelphia, United States Meet Full timeSenior 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 (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...
-
Senior Director, Regulatory Affairs CMC
1 week ago
Philadelphia, United States Meet Full timeSenior 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 (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...
-
Associate Director, Cmc Regulatory Affairs
4 weeks ago
Philadelphia, United States GSK Full time**Site Name**: Durham Blackwell Street, USA - Pennsylvania - Philadelphia **Posted Date**: Apr 17 2024 - Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you! _ This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities...
-
Regulatory Affairs Specialist, Cell
7 days ago
Philadelphia, PA, United States Piper Companies Full timePiper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory...
-
Regulatory Affairs Specialist, Cell
1 week ago
Philadelphia, PA, US Piper Companies Full timePiper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene TherapyCoordinate and manage timing for regulatory submissions,...
-
Regulatory Affairs Specialist, Cell
1 week ago
Philadelphia, PA, US Piper Companies Full timePiper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene TherapyCoordinate and manage timing for regulatory submissions,...
-
Associate/Manager – CMC Regulatory
2 weeks ago
Philadelphia, Pennsylvania, United States Eli Lilly and Company Full timeAt 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...
-
Regulatory Affairs Specialist, Cell
4 days ago
Philadelphia, United States Piper Companies Full timePiper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions,...
-
Regulatory Affairs Specialist, Cell
1 week ago
Philadelphia, United States Piper Companies Full timePiper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene TherapyCoordinate and manage timing for regulatory submissions,...
-
Regulatory Affairs Specialist, Cell
7 days ago
Philadelphia, United States Piper Companies Full timePiper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions,...
-
Philadelphia, United States Cabaletta Bio Full timeMedical Director/Senior Medical Director, Medical Affairs Philadelphia, PA About the Position Reporting to the Vice President, Medical Affairs, we are seeking a highly motivated and experienced Medical Director/Senior Medical Director to join our Medical Affairs team. The incumbent will play a crucial role in shaping and executing the medical affairs...
-
Manager, Regulatory Affairs-hybrid
2 weeks ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...
-
Manager, Regulatory Affairs-hybrid
3 weeks ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...
-
Sr. Regulatory Specialist
7 days ago
Philadelphia, United States ZP Group Full timePiper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part in the regulatory IND submission process of new pharmaceutical...
-
Sr. Director
1 week ago
Philadelphia, United States Eli Lilly and Company Full timeAt 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...
-
Vice President Regulatory Affairs
2 weeks ago
Philadelphia, United States Lumicity Full timeVice President of Regulatory AffairsLumicity is partnered with an exciting biotechnology company that is looking for an experienced regulatory affairs professional. This position would allow you to join an exciting and growing company and lead their growing regulatory team.This position will be based in either San Antonio or Philadelphia.This is a full time,...
-
Philadelphia, United States Adaptimmune Therapeutics plc Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
-
Associate Director, Regulatory Operations-hybrid
3 weeks ago
Philadelphia, United States Adaptimmune Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
-
Philadelphia, United States Adaptimmune Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
-
Regulatory Operations Coordinator
1 week ago
Philadelphia, PA, United States Piper Companies Full timePiper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA . Responsibilities for the Regulatory Operations Coordinator include: Work with internal teams and stakeholders to build IND & CTA...