Director, Regulatory Affairs
Deciphera Pharmaceuticals
Summary
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.
Job description
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
Requirements
- B.S. or M.S. in a scientific discipline
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Annual Bonus
- Long-Term Incentive Plan
- Parental Leave
- Family Planning Benefits
Company overview
Deciphera Pharmaceuticals is a commercial-stage biopharmaceutical company headquartered in Waltham, Massachusetts, with research facilities in Lawrence, Kansas. Founded in 2003, the company specializes in discovering, developing, and commercializing innovative medicines for cancer treatment. As a member of the ONO Group since June 2024, Deciphera leverages its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a diverse portfolio of oncology therapeutics. The company's flagship product, QINLOCK®, is an approved switch-control inhibitor for fourth-line gastrointestinal stromal tumor (GIST), while its pipeline includes multiple clinical-stage candidates targeting various cancers and rare diseases. Deciphera's unique approach targets the switch pocket region of kinases, aiming to generate higher and more durable response rates compared to traditional kinase inhibitors. With a global presence spanning the United States, Europe, and Asia, the company maintains a patient-centric focus, developing transformational medicines to improve the lives of people living with cancer.