Associate Director, Regulatory Affairs

Deciphera Pharmaceuticals • Waltham, MA

45d

About The Position

We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical products. This role partners cross-functionally with R&D, Clinical, Quality, and Commercial teams to ensure regulatory alignment with business objectives and compliance with global health authority requirements. The Associate Director provides expert guidance on regulatory pathways, risk assessment, and submission strategies.

Requirements

• B.S/M.S. and 8+ 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
• Must have experience filing INDs and NDAs and engagement with FDA and other regulatory bodies

Nice To Haves

• Capable of strategic thinking and proposing innovative solutions to regulatory problems
• Demonstrates excellent verbal and written communication skills
• Experience managing a regulatory team member

Responsibilities

• Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage.
• Provide solid regulatory solutions and guidance to the cross-functional teams and senior management.
• Provide tactical support and operational expertise with “hands on” support as needed.
• Assess project plans and timelines.
• Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time.
• Ensure compliance of regulatory strategies and submissions.
• Oversee preparation and review of regulatory submissions and responses.
• Monitor regulatory trends and ensure proactive strategy adjustments.
• Other duties and responsibilities as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees