Manager Regulatory Affairs CMC

Location
Cambridge, Massachusetts
Posted
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

Responsiblities

  • 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 

Qualifications

  • 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)