Head Global Regulatory Affairs
Title: Head Global Regulatory Strategy
Responsibilities:
- Identify global regulatory strategies and global submission plans for established and newly identified indications
- Responsible for global regulatory strategy & submission plans for lead indication
- Coordinate regulatory CMC strategies with RA CMC
- Accountable for US regulatory strategies for all indications in coordination with indication leads
- Serve as the primary point of contact for FDA
- Lead global regulatory affairs team, establishing team goals, norms, responsibilities, and communication plans
- Identify and assess risks associated with product development and recommend strategies to mitigate these risks
- Provide regular updates to leadership, product strategy team, and project leads
- Ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed
Qualifications:
- BSc, MSc, or PhD in a Scientific discipline or Pharmacist
- Minimum 10 years experience in pharmaceutical/biotech, within clinical development Regulatory Affairs
- Hands on skillset in the preparation and submission of INDs, CTAs, NDA/BLAs, or MAAs
- Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU)
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
- Experience interfacing with regulatory agencies and skill at implementing successful global regulatory strategies
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