Manager, Regulatory Affairs

Deciphera Pharmaceuticals

Manager, Regulatory Affairs supporting global regulatory activities across early- and late-stage development programs. Partnering cross-functionally to ensure high-quality regulatory submissions.

Posted 5/21/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $116,000 - $160,000 per yearWebsite

About the role

Key responsibilities & impact

Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures.
Assist in coordination and preparation of global health authority meeting documents.
Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards.
Represents regulatory for global study-level regulatory activities included but not limited to 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, including 4+ years in Regulatory Affairs.
Strong knowledge of U.S. and international regulatory requirements for drug development.
Excellent verbal and written communication, organizational, and 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

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory filingsINDsCTAsamendmentsOrphan drug applicationsAnnual ReportsInvestigator’s Brochuresregulatory strategySOP developmentsubmission support

Soft Skills

communicationorganizationalcross-functional collaborationself-motivatedfast-paced environment

Certifications

Bachelor’s degree