What you will be doing:

• Serve as the primary liaison with US regulatory authorities and is responsible for assisting with the development and implementation of regulatory strategy
• Timely management and preparation of high quality regulatory documents and submissions
• Regulatory life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports, facility/product registrations)
• Act as the company's primary point of contact for FDA
• Establish effective working relationships with Regulatory Agencies and major regulatory consulting agents
• Management of Commercial requests to ensure content of promotional materials is compliant with applicable regulations
• Ensure regulatory applications comply with applicable regulations and guidance documents
• Coordinate the Health Authority response team
• Prepare and organize advice meetings with regulatory authorities
• Represent regulatory as member of Project Team(s) and assure RA input into designated projects

Our ideal candidate will have:

• Advanced life science degree (MS, PhD)
• 8+ years of regulatory affairs experience required, preferably experience with biologics
• Experience in regulatory submissions and post-authorization life-cycle management
• Sound knowledge of FDA guidelines
• Proven direct interactions with FDA

Please apply today!