Sr. Director, Regulatory Affairs CMC

2 weeks ago

West Chester, United States Meet Full time

Exciting opportunity with a global pharmaceutical company dedicated to improving health and quality of life for patients around the world. With a commitment to innovation, quality, and accessibility, they strive to make a meaningful impact in the field of healthcare.


Position Overview: This innovative organization is seeking a highly experienced and motivated Senior Director of Regulatory Chemistry, Manufacturing, and Controls (CMC) to join our dynamic team. The Senior Director will play a pivotal role in leading regulatory CMC strategies and initiatives, ensuring compliance with relevant regulations and guidelines, and driving the successful development and commercialization of our pharmaceutical products.


Key Responsibilities:

  • Develop and implement regulatory CMC strategies to support product development, registration, and commercialization activities.
  • Provide strategic guidance and leadership to cross-functional teams on regulatory requirements, guidelines, and best practices.
  • Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, and variations.
  • Collaborate closely with internal stakeholders, including R&D, Manufacturing, Quality Assurance, and Commercial teams, to achieve regulatory objectives and timelines.
  • Represent the company in interactions with regulatory authorities, including FDA, EMA, and other global health authorities.
  • Stay abreast of evolving regulatory requirements and industry trends, and proactively identify opportunities and risks.
  • Lead and mentor a team of regulatory CMC professionals, fostering a culture of excellence, collaboration, and continuous improvement.


Qualifications:

  • Advanced degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Pharmaceutical Sciences).
  • Extensive experience (minimum 10 years) in regulatory affairs within the pharmaceutical industry, with a focus on CMC.
  • Proven track record of successfully leading regulatory CMC strategies for complex pharmaceutical products, including small molecules and biologics, across various stages of development and commercialization.
  • Strong knowledge of global regulatory requirements, guidelines, and submission processes (FDA, EMA, ICH, etc.).
  • Excellent communication, negotiation, and interpersonal skills, with the ability to effectively collaborate and influence cross-functional teams and external stakeholders.
  • Demonstrated leadership experience, including the ability to mentor and develop regulatory CMC professionals.
  • Strategic mindset, with the ability to think critically, solve problems, and drive results in a fast-paced and dynamic environment.

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