(Senior) Director, Regulatory Affairs
An emerging global biopharmaceutical organization is seeking a Director, Regulatory Affairs to support the advancement of a growing oncology portfolio across the U.S. and Europe. This individual will play a key role in shaping global regulatory strategy, leading major health authority interactions, and driving successful regulatory submissions throughout the product lifecycle.
Key Responsibilities:
- Develop and execute global regulatory strategies supporting clinical development and registration objectives.
- Lead the planning, preparation, and submission of regulatory filings, including INDs, NDAs, BLAs, briefing documents, and health authority responses.
- Serve as the primary regulatory contact with the FDA and other global health authorities.
- Partner closely with cross-functional teams to establish submission strategies, timelines, and regulatory pathways.
- Lead preparation for health authority meetings, including briefing package development, response planning, and meeting facilitation.
- Provide strategic regulatory guidance to development teams on clinical, nonclinical, and CMC matters.
- Coordinate responses to regulatory questions and collaborate with internal stakeholders and external partners to ensure timely submissions.
- Monitor evolving regulatory requirements and assess potential impacts on development and registration strategies.
- Support lifecycle management activities and contribute to long-term regulatory planning.
Qualifications:
- Bachelor's degree in a scientific or healthcare-related discipline required; advanced degree (PhD, PharmD, or equivalent) preferred.
- 10+ years of pharmaceutical or biotechnology industry experience, including regulatory affairs leadership experience.
- Proven track record supporting successful IND, NDA, BLA, and post-approval submissions.
- Experience interacting directly with FDA and other global health authorities.
- Strong understanding of U.S. and European regulatory requirements, GCP regulations, and ICH guidelines.
- Demonstrated ability to develop and execute global regulatory strategies within cross-functional environments.
- Excellent leadership, communication, organizational, and stakeholder management skills.
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