Global Regulatory Strategy Lead, Therapeutics

Monte Rosa Therapeutics, Inc.; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Monte Rosa Therapeutics, Inc. in Basel seeks a Senior Manager / Associate Director, Regulatory Strategy - CMC to lead global regulatory plans for MRT's oncology programs from Basel.

You will manage IND/CTA submissions, coordinate FDA/EMA interactions, oversee regulatory filings, and guide cross‑functional teams to ensure compliant, timely development and approval of innovative therapies. Excellent communication with internal stakeholders and external partners, mentoring junior staff, and

Qualifikationen

• Experience in global regulatory affairs and regulatory strategy.
• Experience managing IND/CTA submissions and related regulatory filings.
• Knowledge of FDA/EMA regulatory requirements and global drug development.
• CMC regulatory knowledge and experience with cross‑functional teams.
• Ability to lead and influence cross‑functional teams and vendors.

Aufgaben

• Develop and execute the regulatory strategy for assigned programs.
• Oversee preparation, submission, and maintenance of regulatory applications (INDs, CTAs, marketing applications).
• Lead FDA/Health Authority interactions and provide strategic guidance.
• Ensure compliance with global regulatory requirements and guidelines.
• Collaborate with internal/external stakeholders and manage vendors/consultants.
• Maintain regulatory files, track commitments, and develop SOPs/work instructions.

Kenntnisse

Global regulatory affairs

Regulatory strategy

IND/CTA submissions

FDA/EMA interactions

CMC knowledge

Cross-functional leadership

Vendor management

Regulatory documents drafting

Ausbildung

Bachelor's degree in health sciences or related field

Advanced degree preferred

Tools

MS Project/Smartsheet

Excel

Word

PowerPoint

Outlook

Jobbeschreibung

Monte Rosa Therapeutics, Inc. in Basel seeks a Senior Manager / Associate Director, Regulatory Strategy - CMC to lead global regulatory plans for MRT's oncology programs from Basel.

You will manage IND/CTA submissions, coordinate FDA/EMA interactions, oversee regulatory filings, and guide cross‑functional teams to ensure compliant, timely development and approval of innovative therapies. Excellent communication with internal stakeholders and external partners, mentoring junior staff, and