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.
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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