Accessibility Links

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).
  • 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.
Similar jobs
Regulatory Publisher (contract)
  • Job type: Contract
  • Location: Bridgewater, New Jersey
  • Salary: Competitive
  • Description Regulatory Publisher (contract) My client is looking to add a Regulatory Publisher to the team for 6-12 months. The Regulatory Publisher will be responsible for participating in the submission
Director of Regulatory Science
  • Job type: Permanent
  • Location: New York
  • Salary: US$150000 - US$210000 per year
  • Description A rapidly growing medical device company is looking to expand their team with a Director of Regulatory Science that is looking to leverage their experience in a start-up environment
Regulatory Affairs Specialist
  • Job type: Permanent
  • Location: New York
  • Salary: US$80000 - US$120000 per year
  • Description A high innovative medical device company is looking for an experience Regulatory Affairs Specialist to join their team as prepare for multiple product launches. Regulatory Affairs Specialist|
Principal Regulatory Affairs Specialist
  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: US$110000 - US$130000 per month
  • Description Description: The Principal Regulatory Affairs Specialist will represent RA on project core teams, provide department and inter-departmental support for assigned projects
Regulatory Affairs Specialist III
  • Job type: Permanent
  • Location: Marlborough, Massachusetts
  • Salary: US$90000 - US$100000 per year
  • Description Regulatory Affairs Specialist III Purpose Statement: The individual will be responsible for helping to set a direction for the organization around the coordination, execution