Director, Regulatory Affairs

Job Description

Director, Regulatory Affairs

Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA will be client facing and will be responsible amongst others for:

• Strategic Advice to clients, with focus on early development through to NDA/ BLA
• Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests.
• Scientific Interaction with internal cross functional teams
• Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities
• Internal BD & marketing facing role

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. * 105+ approved therapies for marketing applications prepared by Veristat * 480+ oncology projects in the past 5 years * 350+ rare disease projects delivered in the past 5 years * Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

Learn more about our core values here ! What we offer* The estimated hiring range for this role is $195K-223K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.

* Benefits vary by location and may include:

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

What we look for

* Bachelor’s degree in science, toxicology, pharmacology, engineering or related field; Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials. * 10 years of