(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.