Senior Director Global Regulatory Lead (Oncology)
Director / Senior Director Global Regulatory Lead (Oncology)
About the Opportunity
Our client is a research-driven biopharmaceutical organization dedicated to advancing innovative therapies for patients with serious diseases worldwide. With a strong commitment to scientific excellence and patient impact, the company is building a diverse oncology portfolio spanning multiple therapeutic modalities, including biologics, antibody-drug conjugates (ADCs), and small molecules.
The organization is seeking a Director/Senior Director Global Regulatory Lead (Oncology) to play a key role in shaping global regulatory strategy for oncology development programs. This individual will provide regulatory leadership across the product lifecycle, driving global development and registration activities while collaborating closely with cross-functional teams and health authorities.
Key Responsibilities
- Lead and execute regulatory activities for one or more complex oncology development programs.
- Serve as the Global Regulatory Lead on cross-functional global project teams.
- Lead or contribute to global regulatory sub-teams and provide strategic regulatory guidance throughout development.
- Act as the primary regulatory contact for key health authority interactions, including the U.S. FDA, and RoW health authorities
- Drive the planning, preparation, and execution of major global regulatory submissions, including NDA, BLA, and MAA applications.
- Ensure regulatory submissions are delivered on time and meet high quality standards.
- Develop and implement global regulatory strategies that support product development, registration, and lifecycle management objectives.
- Partner with regional regulatory teams to ensure alignment and execution of global regulatory plans.
- Communicate regulatory risks, opportunities, and key developments to project teams and leadership.
- Collaborate with cross-functional stakeholders, including clinical, nonclinical, CMC, safety, commercial, and market access teams.
- Monitor evolving regulatory requirements, guidance, and industry trends to proactively inform development strategies.
- Contribute to departmental initiatives, process improvements, and cross-functional working groups.
- Support regulatory due diligence activities related to business development, licensing, or partnership opportunities as needed.
- Identify resource needs and propose solutions to support project objectives.
- Present regulatory strategies, recommendations, and updates to senior leadership and governance committees.
Qualifications
- Bachelor's degree in a scientific discipline required; advanced scientific degree (MS, PhD, PharmD, or equivalent) preferred.
- Minimum of 8 years of pharmaceutical, biotechnology, or related industry experience, including significant regulatory affairs experience.
- Must have prior experience supporting oncology programs in a GRL capacity
- Experience developing and executing regulatory strategies for oncology products required
- Strong knowledge of global drug development and regulatory requirements, with demonstrated experience interacting with the FDA. Familiarity with EMA and other international regulatory agencies is preferred.
- Proven experience supporting or leading major regulatory submissions and contributing to regulatory and development strategies.
- Ability to interpret complex scientific and clinical data and translate findings into effective regulatory strategies.
- Strong leadership, communication, negotiation, and stakeholder management skills.
- Demonstrated ability to work independently while influencing cross-functional and global teams.
- Proven ability to identify regulatory risks, develop mitigation strategies, and provide strategic guidance throughout product development.
- Strong project management skills with the ability to manage competing priorities and timelines in a fast-paced environment.