Associate Director Regulatory Liaison – Oncology

About the role

The Associate Director, Regulatory Liaison supports oncology products within a global regulatory team. You will collaborate with global regulatory leads to develop and implement strategies for product registration and maintenance.

Key responsibilities

• Assist in preparing and submitting regulatory agency communications, including IND applications, marketing applications, pediatric plans, and periodic reports.
• Develop agency background packages, author regulatory strategy documents, and respond to agency requests.
• Participate in global regulatory team meetings and cross‑functional collaborations with Clinical Safety, CMC, Labeling and other functions.
• Conduct research on guidelines, regulatory precedents and competitive intelligence to shape strategy.
• Support lifecycle management, label development and process improvement initiatives.

Required profile

• Bachelor’s degree with at least 5 years of pharmaceutical experience, or Master’s with 2 years, or a doctoral degree with relevant experience.
• Experience in drug development and prior interaction with major regulatory agencies.
• Excellent oral and written communication, strong organizational and analytical skills.
• Flexibility and attention to detail.

Required skills

• Regulatory submissions (IND, marketing applications, pediatric plans)
• Label development
• Life‑cycle planning
• Regulatory strategy formulation

What we offer

• Salary range $129,000 – $203,100 per year, with eligibility for annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation and sick days.
• Hybrid work arrangement.