Director of Regulatory Affairs

As a Director, Regulatory Affairs, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Responsibility will mainly focus on clinical regulatory filings and providing strategic as well as operational leadership on the project teams. In addition, responsibilities will include support to on-going clinical development activities. The candidate will contribute to and/or lead IND/CTA and BLA submissions activities for Regeneron’s products in development and marketed products.
• This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations, with a particular emphasis on US FDA regulations, governing pharmaceutical drug development of all aspects of Regeneron’s quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.
• Developing regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance’s and assessment of drugs developed or precedent information available for similar indications to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines
• Communicating with the FDA and other health authorities for assigned programs
• Managing/leading regulatory activities associated with Regeneron-assigned drug development programs
• Management of the planning, preparation and submission of Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)
• Continually monitoring newly published FDA guidelines and international guidance documents in the context of the new and ongoing development programs

You are:

• 10 years of pharmaceutical industry experience, at least 5 of which are in regulatory affairs
• Strong background in Regulatory Affairs and a history of successful interactions with the Regulatory Agencies
• Candidate should have an M.D., Ph.D. or Pharm. D. degree or equivalent in work experience