Director, Regulatory Affairs

Deciphera Pharmaceuticals

. Serve as regulatory lead for assigned oncology programs, developing and implementing regulatory strategies from FIH through post-marketing stages .

Posted 11/10/2026full-timeRemote • Massachusetts • United StatesLead💰 $196,000 - $245,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in Regulatory Affairs with a focus on oncology drug development, including preparing and submitting INDs and NDAs. Exhibits strong leadership, strategic thinking, and the ability to navigate complex regulatory environments while fostering collaboration across teams.

Highest-signal resume keywords

Regulatory Affairs LeadershipOncology Drug DevelopmentIND and NDA SubmissionGlobal Regulatory ComplianceStrategic Regulatory Planning

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Strategy DevelopmentRegulatory SubmissionsRegulatory Guidelines InterpretationProject ManagementRegulatory Filings Preparation

Soft Skills

Excellent Communication SkillsLeadership and MentorshipCollaborative ApproachDetail-Oriented MindsetProactive Problem Solving

Industry Keywords

Pharmaceutical Regulatory AffairsFDA EngagementGlobal Regulatory AgenciesOncology ProgramsContinuous Improvement Initiatives

About the role

Key responsibilities & impact

Serve as regulatory lead for assigned oncology programs, developing and implementing 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 program impacts to senior leadership
Lead preparation and submission of INDs, NDAs, and other regulatory filings
Ensure submissions are high quality, compliant, and meet global regulatory expectations
Provide hands-on operational oversight for submission preparation, review, and delivery
Collaborate with Clinical Development, Clinical Operations, Quality, and CMC teams
Provide 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
Assess team resources and project priorities to ensure timely delivery of key milestones
Promote a collaborative, solutions-oriented culture within Regulatory Affairs
Contribute to continuous improvement initiatives and implement processes to increase regulatory efficiency
Leverage prior project learnings to optimize global regulatory submissions and strategies
Foster innovation and strategic thinking in regulatory planning and execution
Perform other duties and responsibilities as assigned

Requirements

What you’ll need

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
Ability to lead and manage multiple complex projects simultaneously
Excellent written, verbal, and interpersonal communication skills
Strategic thinking and 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

Comp & perks

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
Long-term incentive plan
Other incentive compensation plans (if applicable)