Head of Regulatory Affairs

Job Title: Head of Regulatory Affairs

Job Number: 32205

Location: Remote, 

Job Description

This exciting new CRO is looking for a Head of Regulatory Affairs who will bring experience across multiple therapeutic areas of regulatory affairs and operations. This is a fully remote opportunity and can be either full-time or contract.

Responsibilities

– Lead the Regulatory function to enable the measured growth and evolution as the company and pipelines grow
– 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- and mid-stage development programs
– Ensure effective risk management and communication of issues/risks across the portfolio, and participate in driving prioritization of resource and spend
– Oversee, plan, 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
– Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

Required Skills

– Bachelor’s or more advanced degree in a scientific discipline
– 8+ years of regulatory experience in the CRO, pharmaceutical, or biotech industry.
– Experience working in a small biotech environment is highly preferred
– Ideally, experience across Oncology, GI, Central Nervous Systems, Ophthalmology, or Dermatology.
– Subject matter expert knowledge of US regulations
– Must be self-motivated and understand the risk and risk management in a small company environment
– Cross-functional collaborative skill set and brings strong analytical thinking and strategic perspective