Sr. Director, Regulatory Affairs Strategy

Senior Director, Global Regulatory Affairs Strategy

The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, 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 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 insure 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

Qualifications

Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory;
PhD or PharmD in above disciplines are preferred
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)
Regulatory agency direct interaction experience
Strong communications skills