Remote Oncology Regulatory Director

Deciphera; United States; Remote; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Annual bonus

Benefits package

Parental leave

Family planning

Zusammenfassung

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for cancer. We are seeking a Regulatory lead for oncology programs to develop strategies from First-In-Human through post-marketing and to provide regulatory input to clinical and development teams.

The role requires advanced knowledge of US and EU regulations, a proven IND/NDA submission track record, and strong leadership to mentor teams while tracking global regulatory trends

Qualifikationen

• Minimum 12 years of experience in pharmaceutical Regulatory Affairs.
• Advanced knowledge interpreting regulations, guidelines, and precedents for oncology drug development in US and EU.
• Proven track record in preparing and submitting INDs, NDAs, and other major regulatory filings.

Aufgaben

• Lead regulatory strategy from FIH through post-marketing for assigned oncology programs.
• Provide regulatory input to clinical and development teams for strategic alignment across functions.
• Monitor global regulatory trends and communicate potential program impacts to senior leadership.

Kenntnisse

Regulatory strategy

IND/NDA submissions

Global regulatory experience (US/EU)

Ausbildung

B.S. or M.S. in a scientific discipline

Jobbeschreibung

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for cancer. We are seeking a Regulatory lead for oncology programs to develop strategies from First-In-Human through post-marketing and to provide regulatory input to clinical and development teams.

The role requires advanced knowledge of US and EU regulations, a proven IND/NDA submission track record, and strong leadership to mentor teams while tracking global regulatory trends