Head of Regulatory Affairs

Head of Regulatory Affairs

Want to join a growing biotech? This is a great opportunity for a Senior Regulatory expert to lead regulatory at Clinical Stage Immunology focused company.

This client is seeking a hands-on head of Regulatory Affairs who will bring broad experience in regulatory affairs and operations along with a roll up the sleeves approach to establish and grow an in-house regulatory function and drive the successful development of an innovative pipeline of novel small molecule targeted therapies.

Responsibilities:

• Build and lead the Regulatory the function enabling the measured growth and evolution from a fully outsourced model as the company and pipeline grows
  • Optimize CRO interactions and lead external regulatory CROs and vendors to drive excellence and meet phase appropriate regulations and timelines
  • Develop and manage Regulatory budgets
  • Develop plans for growth of the regulatory function and hire, manage, and develop Regulatory personnel
• Develop and implement regulatory strategy across a growing pipeline of early development programs, with a focus on the successful registration of these products
  • Enable creative solutions to regulatory challenges to efficiently advance novel cancer therapeutics to key development milestones including positioning for successful pivotal trials and registration
  • Ensure effective risk management and communication of issues/risks across the portfolio, and participate in driving prioritization of resource and spend
  • Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc), preparation and leading of agency meetings
• Serve as the company contact with the FDA and other regulatory authorities
• Direct and assist internal staff and consultants, to ensure the compliance of R&D activities with U.S. and international requirements
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

Qualifications:

1. 12+ years experience in the pharmaceutical or biotech industry. Experience in leading decision-making and working in small biotech environment is highly preferred
2. Experience with Small Molecule drug development from a Regulatory perspective including successful IND and NDA filings.
3. Non-compartmentalized regulatory experience – preclinical, clinical and CMC experience.
4. Ideal candidate is responsible, and excited about building and leading this new division. They will be an integral member of our small development team, and should have the leadership skills to influence, and actively contribute to the team.
5. Other important qualities are thoughtfulness, and strategic thinking. The first stint of this role will be mainly long-range planning.
6. Experience with FDA planning – understanding the issues and able to be proactive and respond to queries
7. Advanced degree preferred, but not required.

If this describes you please don’t hesitate to apply!