Accessibility Links

Senior Manager/AD Regulatory-CMC

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $130000 - $170000 per annum
  • Job reference: MLSN12217
  • Sector: EPM Scientific, Regulatory
  • Date posted: 22/12/2017
Job Summary

An exciting startup biotech company focused on oncology is looking for a Senior Manager/Associate Director RA CMC to join their growing team!
The primary role of this position is to provide regulatory CMC advice and direction, including the interpretation and application of global CMC regulations and guidance, to facilitate the development of products from early phase clinical trials through to worldwide submission and approval.

RESPONSIBILITIES INCLUDE:

  • Participation in or leadership of cross-functional subteams, development of regulatory strategies, and support for oncology development programs
  • Preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, meeting packages, etc.), to ensure timelines are met
  • Preparation of technical assessments of CMC source documentation and responses to technical questions on document content
REQUIREMENTS:
Minimum Education/Experience
  • Bachelor’s or Master’s degree (or equivalent) in life sciences
  • 5+ years of experience in regulatory affairs or related function within a biotechnology company
  • Direct experience managing regulatory CMC aspects of investigational biologic products essential, prefer experience with gene or cell therapy products
Qualifications
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with all levels of management and contract manufacturing organizations
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
  • Strong knowledge of cGMP for biologic products, understanding of biopharmaceutical development, and CMC regulatory affairs
If you are interested, please apply below!
Similar jobs
Global Brand Manager
  • Job type: Permanent
  • Location: Düsseldorf, Nordrhein-Westfalen
  • Salary: Negotiable
  • Description Global Brand Manager This very exciting Pharmaceutical Company is seeking an International Marketeer to build out and represent their leading portfolio of OTC products globally
Global Brand Manager
  • Job type: Permanent
  • Location: Düsseldorf, Nordrhein-Westfalen
  • Salary: Negotiable
  • Description Global Brand Manager This very exciting Pharmaceutical Company is seeking an International Marketeer to build out and represent their leading portfolio of OTC products globally
Clinical Quality Assurance Manager
  • Job type: Permanent
  • Location: Aachen, Nordrhein-Westfalen
  • Salary: Competitive
  • Description Clinical Quality Assurance Manager An innovative and leading pharmaceutical company are hiring a Clinical Quality Assurance Manager to contribute to the continued research and development of their
Account Director
  • Job type: Permanent
  • Location: Munich, Bayern
  • Salary: Negotiable
  • Description Account Director An international pharmaceutical company is currently looking for a Medical Communication Account Director to lead their business, medical and marketing communication strategy
Quality Technician and Inspector
  • Job type: Contract
  • Location: San Francisco, California
  • Salary: Competitive
  • Description Local Medical Device company in search of strong Senior Quality Control Inspector and Quality Technician. We are looking for someone who is not afraid to step in and make a change