Are you ready to lead regulatory strategies that bring innovative therapeutics from development through to marketing approval? As a Director to Sr. Director of Regulatory Affairs, you’ll take the helm of regulatory submissions and strategic planning for successful drug approvals across key markets, including the FDA, EMA, and other regulatory agencies worldwide. If you’re an experienced leader in regulatory affairs, this type offers an impactful opportunity to drive real change.
In this type of role, you can anticipate:
- Developing regulatory strategies that align with multiple pathways, from traditional applications to innovative approaches.
- Guide regulatory submissions, collaborating closely with early development teams to prepare robust IND and NDA packages.
- Lead submission meetings with FDA and other agencies, using creative approaches to optimize outcomes.
- Work with cross-functional teams, ensuring all preclinical, clinical, and CMC requirements are fully met for regulatory compliance.
Who will thrive in this role? You bring 5-10 years of experience in regulatory affairs, particularly within FDA frameworks for biotechnology or related sectors. Strong communication, extensive IND experience, and a strategic mindset are essential for this type of leadership role.
Take the next step to influence groundbreaking developments in drug discovery and regulatory innovation.
