Senior Regulatory Affairs Director - Biotech Portfolio

ELKA Search Partners; Philadelphia (Philadelphia County); On-site; USD 140,000 - 210,000; Full time

Job summary

ELKA Search Partners is seeking an experienced Director, Regulatory Affairs to shape and execute regulatory strategy across the client’s development portfolio. This role demands strategic thinking while staying hands-on to drive execution in a lean biotech environment.

The candidate will lead interactions with FDA and health authorities, coordinate cross-functional teams, and embed regulatory considerations into development plans as programs advance toward clinical and commercial milestones.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred (PharmD, Ph.D, MD).
• 8+ years biotechnology industry experience, including 5+ years in hands-on Regulatory Affairs.
• Experience supporting clinical-stage development programs and regulatory submissions.
• Strong understanding of FDA requirements and the U.S. drug development process.
• Demonstrated ability to contribute to regulatory strategy while also managing hands-on execution.
• Collaborative, proactive and comfortable operating with ownership.

Responsibilities

• Support and execute regulatory strategy across the company's development portfolio.
• Serve as a hands-on regulatory lead for assigned programs and initiatives.
• Lead and support the preparation, review and submission of regulatory documents.
• Support interactions with FDA and other health authorities, including meeting preparation, briefing documents and follow-up activities.
• Partner closely with Clinical Development, CMC, Quality and other cross-functional stakeholders to ensure regulatory considerations are incorporated into development plans.
• Interpret regulatory requirements and health authority feedback, identifying risks, opportunities and potential development pathways.
• Provide clear, actionable regulatory recommendations to internal teams.
• Contribute to the continued development of the company's regulatory infrastructure, processes and best practices as the organization grows.
• Operate with significant visibility and ownership within a lean organization approaching an important stage of clinical and commercial development.

Skills

Regulatory strategy

FDA knowledge

Regulatory submissions

Communication skills

Education

Bachelor's degree in scientific discipline

Advanced degree preferred (PharmD, Ph.D, MD)

Job description

ELKA Search Partners is seeking an experienced Director, Regulatory Affairs to shape and execute regulatory strategy across the client’s development portfolio. This role demands strategic thinking while staying hands-on to drive execution in a lean biotech environment.

The candidate will lead interactions with FDA and health authorities, coordinate cross-functional teams, and embed regulatory considerations into development plans as programs advance toward clinical and commercial milestones.