VP of Regulatory Affairs – Remote, USA

LSR is proud to announce that we’ve partnered with a US-based client who is passionate about providing innovative new drug developments for patients with rare diseases.

We’re looking for a VP of Regulatory Affairs to work closely with our client’s CSO to produce and integrate a regulatory structure and strategy while collaborating with its stakeholders and remaining regulatory compliant with the relevant bodies.

Key Responsibilities:

• Working with the client’s other departments while implementing their regulatory strategy.
• Inform and explain the regulatory needs for the approval of study designs.
• Develop and oversee the direction of regulatory documents and the company’s submissions, such as IND/CTA and BLA/NDA.
• Liaising with the FDA as well as other relevant authorities.

Qualifications & Requirements

• Must carry an MS (minimum) with 15+ years of relevant Regulatory Affairs experience working in Rare Diseases, Endocrinology or other relevant fields.
• Key experience working with FDA guidelines and regulations.
• In-depth knowledge and experience with US regulatory requirements with successful NDA/MAAs.
• Strong experience working with and liaising with the FDA as well as other governing bodies.