Global Head of Regulatory Strategy
Vor 4 Tagen
About This Opportunity
We are seeking a seasoned expert to lead our regulatory team and drive global regulatory strategies.
Responsibilities
- Develop and execute global regulatory strategies to achieve timely regulatory approval in key markets, ensuring strong product positioning.
- Establish and maintain effective relationships with regulatory authorities, including FDA, EMA, and others.
- Oversee the preparation, submission, and maintenance of INDs, CTAs, BLAs, and other regulatory filings.
- Provide regulatory leadership across pipeline projects, working closely with internal teams.
- Guide the strategic development of innovative therapies, navigating complex regulatory landscapes.
- Lead regulatory submissions and approvals, ensuring compliance with evolving regulatory policies.
- Manage and coordinate Health Authority meetings and regulatory engagements.
- Identify potential regulatory challenges and develop proactive solutions, including novel endpoint strategies.
- Represent Regulatory Affairs in partnerships and due diligence activities.
Requirements
- Advanced degree in Life Sciences (PhD, PharmD, or equivalent preferred).
- 15+ years of experience in regulatory affairs within the biopharma industry.
- Proven expertise in oncology regulatory pathways is a plus.
- Strong track record of successful IND/CTA and BLA/MAA filings leading to regulatory approvals.
- Extensive experience interacting with global regulatory agencies (FDA, EMA, etc.).
- Ability to balance strategic vision with hands-on execution in a fast-paced environment.
- Exceptional leadership, negotiation, and communication skills.
- High ethical standards, professional integrity, and the ability to motivate cross-functional teams.
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