Director, Global Oncology Regulatory Strategy

Deciphera Pharmaceuticals Inc.; Waltham (MA); Vor Ort; USD 180.000 - 260.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Annual bonus

Medical insurance

401(k) match

Parental leave

Zusammenfassung

Deciphera Pharmaceuticals Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategies for oncology programs from early development through post-marketing.

The role provides expert guidance to cross-functional teams, drives regulatory submissions, and ensures compliance with global regulations. The ideal candidate will possess at least 12 years in regulatory affairs, with a proven track record submitting INDs and NDAs and interacting with FDA and other global agencies.

Qualifikationen

• BS or MS in a scientific discipline with at least 12 years in pharmaceutical Regulatory Affairs.
• Advanced knowledge of oncology drug development regulations in US and EU.
• Proven track record leading INDs, NDAs, and major regulatory filings.

Aufgaben

• Provide strategic regulatory leadership for assigned oncology programs from early development through post-marketing.
• Lead preparation and submission of INDs, NDAs, and other regulatory filings with cross-functional teams.
• Offer regulatory guidance to clinical, CMC, quality, and development teams to ensure alignment.
• Represent Regulatory Affairs in internal and external meetings with regulators.
• Mentor staff and manage resources to ensure timely milestone delivery.
• Drive process improvements to increase regulatory efficiency and innovation.

Kenntnisse

Regulatory strategy

Leadership

FDA interactions

Cross-functional collaboration

Regulatory submissions

Ausbildung

BS/MS in a scientific discipline

Jobbeschreibung

Deciphera Pharmaceuticals Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategies for oncology programs from early development through post-marketing.

The role provides expert guidance to cross-functional teams, drives regulatory submissions, and ensures compliance with global regulations. The ideal candidate will possess at least 12 years in regulatory affairs, with a proven track record submitting INDs and NDAs and interacting with FDA and other global agencies.