[Hiring] Director, Regulatory Affairs @Deciphera Pharmaceuticals

Role Description

The Director, Regulatory Affairs will join a group of highly motivated regulatory professionals and play a critical role in shaping cohesive regulatory strategies across Deciphera’s product pipeline.

The Director will operate as a strategic regulatory lead, developing and implementing global regulatory strategies for oncology programs from early development through post-marketing. This role will provide expert guidance to cross-functional teams, drive regulatory submissions, and ensure compliance with applicable regulations and industry standards.

Key Responsibilities

• Regulatory Strategy & Leadership
  • Regulatory lead for assigned oncology programs, developing and implementing innovative regulatory strategies from FIH through post-marketing stages.
  • Provide regulatory input to clinical and development teams to ensure strategic alignment across functions.
  • Monitor and interpret global regulatory trends and communicate potential impact on programs to senior leadership.
• Regulatory Submissions & Compliance
  • Lead the preparation and submission of INDs, NDAs, and other regulatory filings in collaboration with cross-functional teams.
  • Ensure all submissions are of high quality, compliant, and meet global regulatory expectations.
  • Provide hands-on operational oversight for submission preparation, review, and delivery.
• Cross-Functional Collaboration
  • Partner with Clinical Development, Clinical Operations, Quality, and CMC teams to ensure regulatory strategy integration across all development activities.
  • Provide timely and accurate regulatory advice to project teams and senior management.
  • Represent Regulatory Affairs at internal and external meetings, including interactions with regulatory authorities.
• Leadership & People Management
  • Provide guidance and mentorship to Regulatory Affairs staff to enhance departmental capabilities.
  • Assess team resources and project priorities to ensure timely delivery of key milestones.
  • Promote a collaborative, solutions-oriented culture within the Regulatory Affairs organization.
• Process Improvement & Innovation
  • Contribute to continuous improvement initiatives and implement new processes to increase regulatory efficiency.
  • Leverage learnings from prior projects to optimize global regulatory submissions and strategies.
  • Foster innovation and strategic thinking in regulatory planning and execution.
• Other duties and responsibilities as assigned.

Qualifications

• B.S. or M.S. in a scientific discipline and a minimum of 12 years of experience in pharmaceutical Regulatory Affairs.
• Advanced knowledge and experience interpreting regulations, guidelines, and precedents related to oncology drug development in the US and EU.
• Proven track record in preparing and submitting INDs, NDAs, and other major regulatory filings.
• Experience engaging with FDA and other global regulatory agencies.
• Demonstrated ability to lead and manage multiple complex projects simultaneously.
• Excellent written, verbal, and interpersonal communication skills.

Requirements

• Strategic thinker with the ability to anticipate regulatory challenges and propose innovative solutions.
• Experience working in oncology drug development at a small-to-midsize biotechnology company.
• Strong leadership and mentorship skills with a collaborative approach.
• Ability to thrive in a fast-paced, cross-functional environment.
• Detail-oriented, proactive, and results-driven mindset.

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.