About the Role
This role is responsible for leading regulatory affairs strategy and execution for key therapeutic assets from preclinical through commercialization. The individual will guide global regulatory submissions, interact with health authorities, and support product approvals and lifecycle planning.
Responsibilities
- Develop and execute global regulatory strategies for assigned assets
- Lead preparation and submission of regulatory dossiers including IND, BLA, and MAA
- Serve as primary regulatory representative for asset teams
- Coordinate interactions with health authorities across regions
- Ensure regulatory compliance throughout product lifecycle
- Guide clinical development plans from regulatory perspective
- Oversee responses to authority questions and requests
- Manage timelines for regulatory milestones
- Collaborate with cross-functional teams on product labeling
- Support post-approval regulatory commitments
- Monitor evolving regulatory requirements in key markets
- Advise on regulatory pathways for new indications
- Lead regulatory aspects of lifecycle management
- Ensure alignment with regional regulatory expectations
- Supervise external regulatory consultants and CROs
- Contribute to regulatory intelligence activities
- Support technology transfer and manufacturing changes
- Review promotional materials for regulatory compliance
- Assist in due diligence for partnerships or acquisitions
- Maintain regulatory project documentation
- Train teams on regulatory requirements
- Drive regulatory strategy for orphan drug designations
- Support pediatric investigation plans where applicable
- Ensure compliance with pharmacovigilance reporting obligations
- Participate in crisis management related to regulatory issues
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model available
Team
Global regulatory affairs team within a biotechnology organization
Why Join Us
- Opportunity to shape regulatory strategy for innovative biologic therapies
- Work in a dynamic, science-driven environment with global impact
- Collaborate with experts across disciplines and geographies
- Be part of a company focused on transforming patient care
- Access to professional development and leadership growth
Available for qualified candidates
