Director, Regulatory Affairs

For our client, we are seeking a Director, Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space. This role will shape US regulatory strategy across the development lifecycle for innovative biopharmaceutical programs. You will serve as a key regulatory partner to internal stakeholders, ensuring alignment with FDA expectations and supporting timely, compliant advancement of the portfolio. The position calls for deep expertise in orphan drugs, strong leadership across global teams, and the ability to guide critical submissions and interactions with health authorities.

Location: Remote – US‑based candidates only (no visa sponsorship available).

Responsibilities

• Develop and implement US regulatory strategy for programs and projects.
• Provide strategic regulatory input on pre‑ and post‑approval activities.
• Serve as the primary FDA contact and liaison.
• Lead preparation of IND, BLA, and NDA documentation.
• Manage timely responses to FDA inquiries.
• Collaborate across cross‑functional teams to ensure regulatory alignment.
• Monitor and interpret changes in the US regulatory landscape.

Qualifications

• 10+ years of regulatory affairs experience in biopharmaceuticals.
• 5–7 years in global leadership roles with a focus on FDA interactions.
• PhD or PharmD preferred.
• Expertise in orphan drugs and drug development.
• Strong understanding of regulatory documents and approval processes.

Benefits

• Participation in short‑term and long‑term incentive programs.
• Comprehensive health benefits package.
• Retirement savings plans.
• Opportunities for professional development.
• Inclusive workplace culture with strong values alignment.

Pay

Compensation: $212,000 – $291,500 annually.