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