A commercialized Biotech client of ours in the rare disease space is looking for a Director of Regulatory Affairs to handle the regulatory affairs efforts for the organization. This position will report directly into the Head of R&D.

Responsibilities:

• File IND's, NDA's, and ensure compliance for their commercialized products
• Lead the Regulatory Affairs division and sit on the leadership team of the company
• Be responsible for post-approval and investigational regulatory submissions to the FDA
• Be responsible for submissions to foreign regulatory authorities such as the EMA
• Be the primary for approval responsibility of regulatory review for advertising and promoted materials of the company's commercialized products 
• Chair the promotional review committee
• Serve as the primary contact with the FDA Office of Prescription Drug Promotion 
• Collaborate cross functionally with other important stakeholders such as marketing, legal, and medical affairs
• Provide regulatory guidance in the preparation and creation of all regulatory documents 

Requirements:

• 5-7 years of experience for review and approval of promotional and advertising materials for a US pharmaceutical company 
• Demonstrated success for INDA and NDA regulatory submissions
• Bachelor's or other professional degree related to the pharmaceutical industry such as biology, chemistry, law, etc. 
• Ability to work in a team environment 
• Ability to work with computer systems to create and submit regulatory submissions 

This role is actively interviewing, so if interested please feel free to contact Marissa at m.saunders@hamlynwilliams.com