Associate Director/Director of Regulatory Affairs

I'm currently partnered with an oncology biotech who is looking to add an experienced Associate Director or Director of Regulatory Affairs to their team.

This is a fantastic opportunity to work within a one-of-a-kind organization with a fantastic culture, significant amount of funding, and assets in both early and late stage. The team has progressed their pipeline significantly over the past several years.

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Key Responsibilities:

• Develop and implement global regulatory strategies to support clinical and commercial goals.

• Lead the preparation and maintenance of regulatory submissions (e.g., IND/CTA, NDA/MAA).

• Draft regulatory documentation and respond to agency questions in collaboration with regulatory operations.

• Lead communications with global health authorities, including preparation of briefing packages, meetings, and follow-up documentation.

• Guide cross-functional teams on regulatory requirements and expedited pathways.

• Assess regulatory risks and provide mitigation strategies to leadership and project teams.

• Ensure full compliance with applicable regulations and internal policies.

• Contribute regulatory insight into development plans, labeling, and post-approval activities.

• Stay informed on evolving regulations and communicate key developments to stakeholders.

Qualifications:

• Bachelor's degree in Life Sciences; advanced degree (PharmD, MS) preferred.

• 5+ years of biotech/pharma industry experience in regulatory affairs.

• Proven success in IND/CTA planning and execution, NDA/post-approval regulatory activities, and drug labeling.

• Exceptional written, verbal, and organizational skills.

• Demonstrated ability to think critically, influence cross-functional teams, and operate with integrity and patient-centered decision-making.

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