Global Regulatory Director, Oncology Submissions

Immunome, Inc.; Bothell (WA); Vor Ort; USD 226.000 - 270.000; Vollzeit

Zusammenfassung

Scorpion Therapeutics seeks a Global Regulatory Lead to shape and execute global regulatory strategies across oncology programs. You will report to the VP, Regulatory Affairs and lead a team through dynamic, cross-functional collaboration.

You will drive regulatory submissions (INDs, BLAs, NDAs), interact with FDA and EMA, and stay ahead of industry changes to maximize global regulatory success in complex programs. This role is based in Bothell, WA.

Qualifikationen

• Bachelor’s degree in a relevant scientific discipline.
• 10+ years of experience in global regulatory affairs in pharma/biotech (or equivalent).
• Proven success leading regulatory submissions and obtaining approvals in major markets.
• Oncology therapeutics experience strongly preferred.

Aufgaben

• Define and implement global regulatory strategies for oncology programs.
• Communicate developments to project teams and stakeholders; anticipate risks and devise solutions.
• Lead the Global Regulatory Team through coaching and mentoring.
• Collaborate with regional regulatory leads and vendors for compliant global submissions.
• Advocate for regulatory positions in governance and cross-functional committees.
• Identify regulatory risks and opportunities; develop mitigation strategies to enhance success rates.
• Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs).
• Act as primary contact with global health authorities and lead FDA meetings.
• Monitor industry trends and regulatory changes and adapt strategies accordingly.

Kenntnisse

Regulatory leadership

Global submissions

FDA/EMA interactions

Oncology experience

Ausbildung

Bachelor’s degree in a scientific field

Jobbeschreibung

Scorpion Therapeutics seeks a Global Regulatory Lead to shape and execute global regulatory strategies across oncology programs. You will report to the VP, Regulatory Affairs and lead a team through dynamic, cross-functional collaboration.

You will drive regulatory submissions (INDs, BLAs, NDAs), interact with FDA and EMA, and stay ahead of industry changes to maximize global regulatory success in complex programs. This role is based in Bothell, WA.