Strategic Director, Regulatory CMC

Madrigal Pharmaceuticals; Waltham (MA); Hybrid; USD 259,000 - 293,000; Full time

Benefits offered by this job

Equity in rewards

Flexible paid time off

Medical, dental, vision insurance

401(k) with employer match

Employee Assistance Program

Mental health benefits

Job summary

Madrigal is seeking a Senior Director of Regulatory Affairs CMC to lead regulatory CMC strategy for development and commercial products, including submissions and post-approval activities. You will chair cross-functional teams and interface with Health Authorities.

The role requires at least 15 years of regulatory CMC experience, strong communication and negotiation skills, and a hybrid in-office schedule in Waltham, MA or Conshohocken, PA.

Qualifications

• BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
• Minimum 15 years’ regulatory CMC experience with broad-based CMC technical and product experience.
• Strategic regulatory CMC experience with a track record in clinical, commercialization and lifecycle management of small molecule products.
• Experience interacting with global Health Authorities on CMC topics.
• Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals.
• Excellent communication and negotiation skills; able to present scientific cases to SMEs and regulators.
• Hybrid opportunity (3 days per week in office) based in our Waltham, MA or Conshohocken, PA offices.

Responsibilities

• Independently develops and leads execution of regulatory CMC strategies for products in the investigational, registration and post-approval lifecycle.
• Applies expert regulatory CMC knowledge to overcome challenges during development and commercialization.
• Guides strategy for CMC dossier content and writes/reviews content for conformance with Health Authority requirements.
• Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings on CMC topics.
• Provides global regulatory input to quality-related activities, including inspections and regulatory impact assessments for change controls, deviations and investigations.
• Proactively identifies regulatory CMC risks and develops mitigation strategies with timely communication to management.
• Monitors, interprets, and communicates relevant CMC global regulatory requirements and trends.

Skills

Regulatory strategy

Cross-functional collaboration

Communication skills

Negotiation skills

Global Health Authority interaction

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Madrigal is seeking a Senior Director of Regulatory Affairs CMC to lead regulatory CMC strategy for development and commercial products, including submissions and post-approval activities. You will chair cross-functional teams and interface with Health Authorities.

The role requires at least 15 years of regulatory CMC experience, strong communication and negotiation skills, and a hybrid in-office schedule in Waltham, MA or Conshohocken, PA.