RH Talent
Overview
An emerging, well-funded biotech company developing next-generation biologics is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy across its oncology portfolio. This individual will be instrumental in guiding programs from IND through pivotal stages, partnering cross-functionally to ensure alignment between regulatory, clinical, CMC, and executive leadership teams.
Responsibilities
Define and drive global regulatory strategy for oncology assets, ensuring alignment with corporate goals and evolving regulatory expectations.
Lead preparation, submission, and maintenance of regulatory filings.
Serve as the primary liaison with the FDA, EMA, and other global health authorities, managing briefing packages, meeting requests, and written communications.
Provide regulatory insight into clinical development plans, study protocols, and risk assessments.
Partner closely with cross-functional leaders in Clinical Development, CMC, Nonclinical, and Quality to ensure cohesive program execution, while leading and managing a team.
Requirements
Advanced degree in life sciences; PharmD or PhD preferred.
10+ years of experience in Regulatory Affairs within the biotech or pharmaceutical industry, including substantial oncology experience.
Proven track record leading successful INDs and/or BLAs for biologics.
Deep understanding of global regulatory frameworks, ICH, and GxP standards.
Excellent communication, leadership, and cross-functional collaboration skills.
Demonstrated ability to operate effectively in a fast-paced, entrepreneurial environment.
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
Benefits
401(k)
Medical insurance
Vision insurance
#J-18808-Ljbffr
Responsibilities
Define and drive global regulatory strategy for oncology assets, ensuring alignment with corporate goals and evolving regulatory expectations.
Lead preparation, submission, and maintenance of regulatory filings.
Serve as the primary liaison with the FDA, EMA, and other global health authorities, managing briefing packages, meeting requests, and written communications.
Provide regulatory insight into clinical development plans, study protocols, and risk assessments.
Partner closely with cross-functional leaders in Clinical Development, CMC, Nonclinical, and Quality to ensure cohesive program execution, while leading and managing a team.
Requirements
Advanced degree in life sciences; PharmD or PhD preferred.
10+ years of experience in Regulatory Affairs within the biotech or pharmaceutical industry, including substantial oncology experience.
Proven track record leading successful INDs and/or BLAs for biologics.
Deep understanding of global regulatory frameworks, ICH, and GxP standards.
Excellent communication, leadership, and cross-functional collaboration skills.
Demonstrated ability to operate effectively in a fast-paced, entrepreneurial environment.
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
Benefits
401(k)
Medical insurance
Vision insurance
#J-18808-Ljbffr