Director, Regulatory Affairs
About The Position
The Director, Regulatory Affairs will join Deciphera’s regulatory team and shape cohesive regulatory strategies across the product pipeline. The role serves as the strategic regulatory lead for assigned oncology programs, developing and implementing global regulatory strategies from early development through post-marketing. The Director provides expert guidance to cross-functional teams, leads regulatory submissions, and ensures compliance with applicable regulations and industry standards. The position includes strategic and operational oversight of regulatory filings, collaboration with clinical, quality, and CMC functions, engagement with regulatory authorities, and mentorship of Regulatory Affairs staff. The Director also contributes to process improvement and innovation in regulatory planning and execution.
Requirements
- B.S. or M.S. in a scientific discipline.
- At least 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 preparing and submitting INDs, NDAs, and other major regulatory filings.
- Experience engaging with the FDA and other global regulatory agencies.
- Demonstrated ability to lead and manage multiple complex projects simultaneously.
- Excellent written, verbal, and interpersonal communication skills.
Nice To Haves
- 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.
Responsibilities
- Develop and implement global regulatory strategies for assigned oncology programs from first-in-human development through post-marketing.
- Provide regulatory input to clinical and development teams to ensure strategic alignment across functions.
- Monitor and interpret global regulatory trends and communicate potential program impacts to senior leadership.
- Lead preparation and submission of INDs, NDAs, and other regulatory filings in collaboration with cross-functional teams.
- Ensure submissions are high quality, compliant, and meet global regulatory expectations.
- Provide hands-on operational oversight for regulatory submission preparation, review, and delivery.
- Partner with Clinical Development, Clinical Operations, Quality, and CMC teams to integrate regulatory strategy across 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.
- Guide and mentor Regulatory Affairs staff and assess team resources and project priorities to support timely delivery of milestones.
- Promote a collaborative, solutions-oriented culture within Regulatory Affairs.
- Contribute to continuous improvement initiatives and implement processes to increase regulatory efficiency.
- Apply learnings from prior projects to optimize global regulatory submissions and strategies.
- Foster innovation and strategic thinking in regulatory planning and execution.
- Perform other duties and responsibilities as assigned.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, and vision insurance, and a 401(k) retirement plan with company match.
- Parental leave and family planning benefits.
- Personal and professional growth opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
