Full-Time Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline.

Role Responsibilities

• Develop regulatory strategies for oncology development programs
• Provide solid regulatory solutions and guidance to cross-functional teams and senior management
• Monitor global regulatory changes that may impact asset development
• Ensure compliance of regulatory strategies and submissions

Qualifications

• B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs
• 5+ years of regulatory experience working with global development and submission plans
• Advanced knowledge and experience in interpretation of regulations, guidelines, and precedents related to oncology drug development in the US and EU
• Experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies

Compensation

The base salary pay range for this role is $158,000.00 - $217,000.00.

Benefits

• Competitive salary and annual bonus
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more
• Generous parental leave and family planning benefits
• Outstanding culture and opportunities for personal and professional growth

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