B.S. or M.S. in a scientific discipline with 12+ years in pharmaceutical Regulatory Affairs.
Advanced knowledge of oncology drug development regulations in the US and EU.
Proven experience with INDs, NDAs, and major regulatory filings.
Engagement experience with FDA and global regulatory agencies.
Ability to manage multiple complex projects simultaneously.
Strong communication skills, both written and verbal.
Responsibilities
Lead regulatory strategy for oncology programs from early development to post-marketing.
Provide regulatory input to ensure alignment across clinical and development teams.
Monitor global regulatory trends and communicate impacts to senior leadership.
Prepare and submit INDs, NDAs, and other regulatory filings with cross-functional teams.
Ensure high-quality, compliant submissions that meet global expectations.
Offer operational oversight for submission preparation and delivery.
Collaborate with various teams to integrate regulatory strategies across development activities.
Benefits
Comprehensive benefits package including medical, dental, and vision insurance.
401(k) retirement plan with company match.
Generous parental leave and family planning benefits.
Opportunities for personal and professional growth.
Outstanding company culture.
Full Job Description
Job 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.
Preferred Capabilities
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.
Additional Information
Deciphera believes in providing a fair, equitable, and competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
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.
About Deciphera Pharmaceuticals, Inc.
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines to improve the lives of cancer patients. The company's drug candidates include ripretinib, a broad-spectrum KIT and PDGFR? inhibitor, and DCC-3014, a selective inhibitor of CSF1R. Ripretinib is in clinical development for the treatment of gastrointestinal stromal tumors (GIST), systemic mastocytosis (SM), and other solid tumors. DCC-3014 is in Phase 1 clinical development for the treatment of solid tumors. Deciphera Pharmaceuticals is headquartered in Waltham, Massachusetts.
