Regulatory Strategy Lead – Global CMC for Oncology

Monte Rosa Therapeutics; Basel; On-site; CHF 180,000 - 240,000; Full time

Job summary

Monte Rosa Therapeutics is seeking a Senior Manager / Associate Director, Regulatory Strategy - CMC to lead regulatory strategy across oncology, immunology, and related areas from Basel. You will manage IND/CTA filings, interact with FDA/EMA, and ensure global compliance while partnering with internal and external stakeholders.

The role requires 5+ years in global regulatory affairs, strong program management, and the ability to drive submissions and strategy across cross-functional teams in a

Qualifications

• Bachelor's degree in health sciences or related field, or an advanced degree is preferred.
• Minimum of 5 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
• Hands-on experience in managing the preparation and timely submission of regulatory applications.
• Regulatory expedited program submissions, CMC, and EU CTA experience is a plus.
• In-depth knowledge of global regulatory requirements, guidelines, and processes for drug development and approval.
• Strong computer skills, including Excel, Word, PowerPoint, Outlook, and MS Project/Smartsheet.
• Experience with managing third-party vendors, regulatory operations, and consultants is a plus.
• Ability to build and maintain effective working relationships with internal and external stakeholders.

Responsibilities

• Develop and execute the Regulatory strategy for assigned programs in alignment with corporate goals.
• Oversee preparation, submission, and maintenance of regulatory applications (INDs, CTAs, marketing applications, annual reports, designations).
• Lead and manage FDA and Health Authority interactions, including meetings and written communications.
• Ensure compliance with global regulatory requirements and guidelines (FDA, EMA, and others).
• Represent Regulatory on cross-functional product teams and provide strategic guidance.
• Collaborate with stakeholders, manage third-party vendors and consultants for submissions.
• Maintain regulatory files and databases, track commitments, and develop SOPs and related docs.
• Maintain knowledge of laws, guidance, and requirements for assigned programs.

Skills

Relationship building

Cross-functional collaboration

Regulatory affairs knowledge

Education

Bachelor's degree in health sciences or related field

Advanced degree preferred

Tools

Excel

Word

PowerPoint

Outlook

MS Project/Smartsheet

Job description

Monte Rosa Therapeutics is seeking a Senior Manager / Associate Director, Regulatory Strategy - CMC to lead regulatory strategy across oncology, immunology, and related areas from Basel. You will manage IND/CTA filings, interact with FDA/EMA, and ensure global compliance while partnering with internal and external stakeholders.

The role requires 5+ years in global regulatory affairs, strong program management, and the ability to drive submissions and strategy across cross-functional teams in a