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Director Regulatory Affairs-CMC

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $160000 - $200000 per annum
  • Job reference: MLSN121917
  • Sector: EPM Scientific, Regulatory
  • Date posted: 19/12/2017
A growing bio-pharmaceutical company is searching for a Regulatory Director-CMC. This role is accountable for the development and implement global regulatory chemistry, manufacturing, and control (CMC) strategies for small molecules products from development through marketing approval for the US and EU markets.

Responsibilities: .
  • Assists in the responsibility for regulatory project timelines and management of IND/NDA and global regulatory submissions.
  • Lead regulatory activities including planning, drafting, reviewing and submission of chemistry manufacturing and control (CMC) sections of regulatory submissions.
  • Ensure compliance with FDA and international regulations and guidelines.
  • Support IND and NDA applications including responsibility amendments, supplements, and annual reports.
  • Provide global CMC regulatory guidance, especially as it pertains to current thinking related to small molecule products.
  • Provide proactive CMC regulatory intelligence in areas of a competitive nature and keep abreast of changes in agency regulations and requirements (e.g. FDA, EMEA, ROW).
Qualifications:
  • BS/MD or PhD in relevant discipline
  • A minimum of 10 years of experience in CMC regulatory project management, development, scale-up and clinical/commercial development and manufacturing in the pharmaceutical industry.
  • Knowledge of global CMC-related regulatory requirements and guidelines an advantage.
  • Experience in the conduct of global clinical trial programs including Phase 3.
  • Demonstrated consistent achievement of team delivery against commitments and goals.
  • A strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies.
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