Director, Global Regulatory Strategy - Oncology

Deciphera Pharmaceuticals; Waltham (MA); Vor Ort; USD 196.000 - 245.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Annual bonus

401(k) with company match

Parental leave

Zusammenfassung

Deciphera Pharmaceuticals in Waltham, MA is seeking a Director of Regulatory Affairs to shape global regulatory strategies across its oncology programs from early development through post-marketing. This leadership role provides expert guidance to cross-functional teams, drives submissions, and ensures compliance with US/EU regulations.

The director will mentor staff and foster a culture of continuous improvement.

Qualifikationen

• Minimum of a BS or MS in a scientific discipline with extensive regulatory affairs experience.
• Expertise in US/EU oncology regulatory development and IND/NDA submissions.
• Proven ability to lead cross-functional teams and influence senior management.
• Experience engaging with the FDA and global regulatory agencies.

Aufgaben

• Regulatory Strategy & Leadership: lead for oncology programs from FIH through post-marketing.
• Regulatory Submissions & Compliance: oversee IND/NDA filings with cross-functional teams.
• Cross-Functional Collaboration: partner with Clinical, Quality, and CMC teams to align regulatory plans.
• Leadership & People Management: mentor Regulatory Affairs staff and manage resources.
• Process Improvement & Innovation: drive continuous improvement in regulatory efficiency.

Kenntnisse

Regulatory strategy

IND/NDAs submissions

FDA engagement

Leadership

Ausbildung

B.S./M.S. in scientific discipline

Jobbeschreibung

Deciphera Pharmaceuticals in Waltham, MA is seeking a Director of Regulatory Affairs to shape global regulatory strategies across its oncology programs from early development through post-marketing. This leadership role provides expert guidance to cross-functional teams, drives submissions, and ensures compliance with US/EU regulations.

The director will mentor staff and foster a culture of continuous improvement.