Director, CMC Regulatory Strategy & Submissions

Madrigalpharma; Waltham (MA); On-site; USD 207,000 - 253,000; Full time

Benefits offered by this job

Equity participation

Flexible paid time off

Comprehensive health benefits

Job summary

Madrigalpharma in Waltham is looking for a Director, Regulatory Affairs CMC to drive regulatory strategies for clinical trials and market approvals. Key responsibilities include leading CMC regulatory dossier development and engaging with Health Authorities.

The ideal candidate has a BS in life sciences, over 12 years of experience including regulatory CMC, and excellent communication skills. This full-time role offers a salary between $207,000 and $253,000 annually, along with equity opportunities and competitive benefits.

Qualifications

• Minimum 12 years relevant experience.
• 8-10 years’ regulatory CMC experience.
• Strong knowledge of global pharmaceutical regulations.

Responsibilities

• Develop and execute regulatory CMC strategies.
• Guide regulatory dossier content.
• Represent Madrigal in Health Authority meetings.

Skills

Regulatory CMC knowledge

Communication skills

Negotiation skills

Education

BS in life sciences or equivalent

Advanced degree preferred

Job description

Madrigalpharma in Waltham is looking for a Director, Regulatory Affairs CMC to drive regulatory strategies for clinical trials and market approvals. Key responsibilities include leading CMC regulatory dossier development and engaging with Health Authorities.

The ideal candidate has a BS in life sciences, over 12 years of experience including regulatory CMC, and excellent communication skills. This full-time role offers a salary between $207,000 and $253,000 annually, along with equity opportunities and competitive benefits.