Senior Director, Regulatory Affairs CMC
Found in: Appcast Linkedin GBL C2 - 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
-
Senior Director, Regulatory Affairs CMC
3 days ago
Philadelphia, United States CareerBuilder Full timeSenior 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 CMC
Found in: Jooble US O C2 - 1 week ago
Philadelphia, PA, United States Meet Recruitment Limited Full timeSenior 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
Found in: Jooble US O C2 - 2 days ago
Philadelphia, PA, United States Meet Full timeSenior 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
1 week ago
Philadelphia, United States CareerBuilder Full timeOur client, a top pharmaceutical company with an innovative approach to medicine and patient care, is seeking a highly experienced Senior Director for their Regulatory Affairs CMC - Biologics team. The ideal candidate will have extensive experience working within large pharma organizations and possess exceptional leadership skills. Responsibilities: -Leading...
-
Senior Director, Regulatory Implementation and Risk Management
Found in: Jooble US O C2 - 1 week ago
Philadelphia, PA, United States Meet Recruitment Limited Full timeSenior 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...
-
Director Regulatory CMC
6 days ago
Philadelphia, United States Spark Therapeutics Inc Full timeJoin the Spark Team We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. We don't follow footsteps. We create the path. Primary Duties Reporting to the Head of Regulatory CMC...
-
Associate/Manager – CMC Regulatory
Found in: beBee jobs US - 1 week 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...
-
Associate/Manager – CMC Regulatory
Found in: beBee jobs US - 3 days 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...
-
Associate/Manager â CMC Regulatory
Found in: beBee S US - 2 weeks 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...
-
Manager, Regulatory Affairs-hybrid
1 week ago
Philadelphia, United States Adaptimmune Full timeAdaptimmune 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 multiple solid tumors. Our company...
-
Manager, Regulatory Affairs-hybrid
1 week 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...
-
Vice President, Global Regulatory Affairs
1 week ago
Philadelphia, United States CareerBuilder Full timeVice President, Global Regulatory Affairs Confidential Philadelphia, PA Mar 02, 2024 Executive Science Job Description Vice President, Global Regulatory Affairs About the Company Leading life sciences, pharmaceuticals & medical diagnostics company Industry Biotechnology Type Public Company Founded 1999 Employees 10,001 Categories Information Technology &...
-
Director of Federal Affairs
1 week ago
Philadelphia, United States University of Pennsylvania Full timeThe Director of Federal Affairs in the Office of Government and Community Affairs will develop and manage comprehensive strategic advocacy programs to advance the University's interests with federal government. Administer programs for securing suppor Director, Government, Education, Management, Healthcare, University
-
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 timeJob DescriptionJob DescriptionAdaptimmune 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...
-
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune 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...
-
Philadelphia, United States CTTX Health Full timeSenior Director of Surgical Services and AnesthesiaCTTX Health is seeking an experienced and innovative Senior Director of Surgical Services and Anesthesia to join our team. As the Senior Director, you will oversee and coordinate the operations and strategic planning of the surgical services department and anesthesia services.At CTTX Health, we are dedicated...
-
Philadelphia, United States CareerBuilder Full timeOur client is a specialty pharmaceutical company committed to helping everyone they serve live their best life through the delivery of quality, life-enhancing therapies. Their decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, they boldly transform insights into treatments...
-
Senior Associate, Regulatory Promotional Operations
Found in: Resume Library US A2 - 1 week ago
Philadelphia, Pennsylvania, United States Digitas Health Full timeJob Description The Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and...
-
Philadelphia, United States CTTX Health Full timeSenior Director of Surgical Services and Anesthesia CTTX Health is seeking an experienced and innovative Senior Director of Surgical Services and Anesthesia to join our team. As the Senior Director, you will oversee and coordinate the operations and strategic planning of the surgical services department and anesthesia services. At CTTX Health, we are...