Manager, Regulatory Affairs

Deciphera Pharmaceuticals

. Support global regulatory activities across early- and late-stage development programs through lifecycle management .

Posted 10/21/2026full-timeRemote • Waltham • Massachusetts • United StatesMid-LevelSenior💰 $116,000 - $160,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a strong focus on U.S. and international regulatory requirements for drug development, including INDs, CTAs, and NDA submissions. Proven ability to collaborate cross-functionally and support high-quality regulatory submissions while ensuring compliance with health authority standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceINDs/CTAs SubmissionU.S. Regulatory RequirementsCross-Functional CollaborationPharmaceutical Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyRegulatory Filings PreparationQuality Standards ComplianceLifecycle ManagementHealth Authority InteractionsSOP DevelopmentAmendments and Information RequisitionsOrphan Drug ApplicationsAnnual ReportsInvestigator’s Brochures

Soft Skills

Excellent Communication SkillsStrong Organizational SkillsSelf-MotivatedFast-Paced Environment Adaptability

Industry Keywords

Pharmaceutical IndustryRegulatory SubmissionsGlobal Health AuthoritiesStudy Start-UpStudy MaintenanceEnd-of-Trial ActivitiesContinuous Improvement Initiatives

About the role

Key responsibilities & impact

Support global regulatory activities across early- and late-stage development programs through lifecycle management
Partner cross-functionally to support high-quality regulatory submissions
Help drive successful interactions with global health authorities
Support regulatory strategy and execution for INDs, CTAs, NDA components, supplements, and other product-related regulatory activities
Prepare, review, and submit regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures
Assist with coordination and preparation of global health authority meeting documents
Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards
Represent Regulatory Affairs for global study-level activities, including study start-up, study maintenance, and end-of-trial activities
Collaborate with external partners and vendors on regulatory activities and submission support
Support regulatory operations and continuous improvement initiatives, including work instruction and SOP development and maintenance

Requirements

What you’ll need

Bachelor’s degree, preferably in a scientific discipline
6+ years of pharmaceutical industry experience
4+ years in Regulatory Affairs
Strong knowledge of U.S. and international regulatory requirements for drug development
Excellent verbal and written communication skills
Strong organizational skills
Strong cross-functional collaboration skills
Strong experience in a self-motivated, fast-paced environment
Experience supporting initial INDs/CTAs and initial marketing application activities is highly desirable

Benefits

Comp & perks

Equity-based compensation
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan with company match
Life insurance
Flexible spending account for health care and/or dependent care
Annual performance bonus
Long-term incentive plan
Generous parental leave
Family planning benefits
Opportunities for personal and professional growth