Manager Regulatory Affairs CMC

Cambridge, Massachusetts
Feb 27, 2018
Required Education
Bachelors Degree
Position Type
Full time


Responsible for providing global CMC Regulatory support for multiple oligonucleotide programs in development:

  • Develop and manage CMC aspects of global regulatory plans including the content generation for IND and CTA filings for multiple oligonucleotide programs
  • Contribute to the preparation of health authority meeting background packages
  • Support the pharmaceutical development organization as it relates to Regulatory CMC and drug development requirements


  • Lead global CMC submission teams for the lifecycle management and initial filings of development products
  • Engage and advise global CMC team relative to regulatory guidance and requirements for submission dossiers and to support product development
  • Track and evaluate Regulatory policy and guidance relative to CMC specific issues.
  • Keep abreast of scientific developments in key CMC areas, including quality by design
  • Keep Regulatory leadership informed on plans/risks/issues
  • Author as appropriate and coordinate assembly and publishing of CMC regulatory documents for filings 


  • Bachelor’s Degree in Pharmacy, Chemistry, Biology, or a related specialty 
  • Masters in Regulatory Affairs desired
  • 5-10 years of combined experience in pharmaceutical/biotechnology industry: Analytical Development, Formulation Development, Chemistry Development or Regulatory Affairs
  • Strong knowledge of US CMC regulations and policies/guidelines; good knowledge of other regional regulatory requirements (EU)
  • Strong communication and negotiations skills
  • Strong analytical skills & capacity to summarize situations; strong writing skills
  • Strong project management skills
  • Strong interest in learning
  • MS Outlook, PowerPoint, Word, Excel
  • Electronic submissions (eCTD)