Senior Director, Regulatory Affairs CMC

2 weeks ago


Philadelphia, United States Meet Full time

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 (biologics) 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)
  • Biologics background highly preferred


Please reach out to Ryan Moran to learn more about this position:

ryan.moran@peoplewithchemistry.com



  • Philadelphia, PA, United States Meet Full time

    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 (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be...


  • Philadelphia, Pennsylvania, United States Proclinical Full time

    Associate Director of Regulatory Affairs - Permanent - OnsiteProclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program. This is a permanent role located in Philadelphia, PA.Primary ResponsibilitiesThis position is responsible for leading the development, review, and execution of regulatory strategy and...


  • Philadelphia, Pennsylvania, United States Eli Lilly and Company Full time

    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...


  • Philadelphia, United States Piper Companies Full time

    Piper 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 Piper Companies Full time

    Piper 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 time

    Medical 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...


  • Philadelphia, United States Piper Companies Full time

    Piper 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,...


  • Philadelphia, United States Piper Companies Full time

    Piper 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, PA, United States Piper Companies Full time

    Piper 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...


  • Philadelphia, PA, US Piper Companies Full time

    Piper 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,...


  • Philadelphia, United States ZP Group Full time

    Piper 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

    4 weeks ago


    Philadelphia, United States Eli Lilly and Company Full time

    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...


  • Philadelphia, United States Piper Companies Full time

    Piper 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 products.Responsibilities...


  • Philadelphia, United States Piper Companies Full time

    Piper 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 products. ...


  • Philadelphia, PA, United States Piper Companies Full time

    Piper 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 products. ...


  • Philadelphia, PA, US Piper Companies Full time

    Piper 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 products.Responsibilities...


  • Philadelphia, PA, US Piper Companies Full time

    Piper 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 products.Responsibilities...


  • Philadelphia, United States City of Philadelphia Full time

    **Company Description** A best-in-class city that attracts best-in-class talent, Philadelphia is an incredible place to build a career. From our thriving arts scene and rich history to our culture of passion and grit, there are countless reasons to love living and working here. With a workforce of over 30,000 people, and more than 1,000 different job...


  • Philadelphia, United States Chubb Full time

    The **VP, Government Affairs **will be responsible for Pennsylvania (including Philadelphia municipal issues) and the rest of the Mid-Atlantic Region of the U.S., which includes Delaware, Virginia, West Virginia, Maryland, North Carolina, South Carolina, Kentucky, Tennessee and Washington, D.C. The role will preferably be located in Pennsylvania with...


  • Philadelphia, United States The Medical Affairs Company Full time

    Director of Medical Science Liaison (MSL), Pediatric Gene Editing, Biotech (Philly Area) TMAC's direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma's Complete Recruiting Resource. We were recognized by Forbes as a Top Executive Search Firm in the US. Thank you for taking the time to review this opening! A gene editing...