Director, Global Regulatory Affairs Strategist

Alternative Resources Company

Director, Global Regulatory Affairs Strategist

Director, Global Regulatory Affairs Strategist
 
The position will provide strategic regulatory affairs leadership for the company and supported novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.
 
Responsibilities
  • Develop and execute novel drug regulatory strategy
  • Ensure company’s development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
  • Strong project management skills and strong interpersonal skills to handle complex distributed programs
  • Ability to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messaging
  • Work closely with regulatory CMC lead and overall development team to ensure overall regulatory strategy and regulatory CMC strategy are aligned
  • Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison for the company
 
Requirements
  • Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is required; PhD or PharmD in above disciplines is preferred
  • 7-10 years industry experience a must with RA novel drug development
  • CMC and/or Botanical experience, RAC certification
  • Thorough understanding of ICH and US CFR requirements and regulations.
  • Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
  • Experience in direct interaction with Regulatory agencies
  • Strong communications skills