Regulatory CMC Director

2 weeks ago


Beijing, Beijing, China Pfizer Full time
Job Description

Pfizer is seeking a highly skilled Regulatory CMC Director to join our team in China. As a key member of our GRS CMC China team, you will be responsible for leading the development and execution of global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.

Main Responsibilities
  • Collaborate with cross-functional colleagues to leverage and share technical and regulatory knowledge, align expectations, and manage planning and monitoring activities to mitigate risks.
  • Deliver high-quality regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.
  • Maintain the expansive combination of CMC product information, market registration details, component-level dossier content, and compliance of an integrated regulatory change management process.
  • Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Prepare regulatory assessments, develop, and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
Qualifications
  • BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines; an advanced degree is preferred.
  • Technical discipline with 9+ years of experience in the pharmaceutical industry, with relevant technical experience (QA, Technical Services, Operations, Manufacturing, or R&D) and 4+ years of pharmaceutical regulatory experience is desired.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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