Global Director, Regulatory CMC & Submissions

Regulatory Jobs; Waltham (MA); Hybrid; USD 259.000 - 293.000; Vollzeit

Benefits dieser Stelle

Equity

Comprehensive benefits

Flexible PTO

401(k) plan

Zusammenfassung

Madrigal is a biopharmaceutical company innovating therapies for metabolic diseases. The Senior Director of Regulatory Affairs CMC provides strategic regulatory CMC leadership for clinical trials, registrations, and post-approval activities, coordinating cross-functional teams and planning submissions to Health Authorities.

Responsibilities include defining dossier content, guiding regulatory strategy, and representing the function in Health Authority meetings.

Qualifikationen

• BS in life sciences or equivalent experience; advanced degree strongly preferred.
• Minimum 15 years regulatory CMC experience with broad CMC knowledge across development, registration, and lifecycle management.
• Experience interacting with global Health Authorities on CMC topics is required.
• Excellent communication and negotiation skills; ability to present scientific cases to SMEs and regulators.
• Hybrid role with 3 days in office, based in Waltham, MA or Conshohocken, PA.

Aufgaben

• Develops and leads regulatory CMC strategies for investigational, registered, and post-approval products.
• Applies regulatory CMC knowledge to overcome development and commercialization challenges.
• Writes/reviews CMC dossier content to meet Health Authority requirements.
• Represents regulatory CMC in Health Authority meetings and prepares for meetings on CMC topics.
• Provides regulatory input to quality activities including inspections and change controls.
• Identifies CMC risks and develops mitigation strategies; communicates with line management.
• Monitors and interprets global CMC requirements and emerging trends.

Kenntnisse

Strategic regulatory CMC leadership

Cross-functional collaboration

Global Health Authority interactions

Executive communication skills

Regulatory submission planning

Ausbildung

Bachelor's degree in life sciences

Advanced degree preferred

Jobbeschreibung

Madrigal is a biopharmaceutical company innovating therapies for metabolic diseases. The Senior Director of Regulatory Affairs CMC provides strategic regulatory CMC leadership for clinical trials, registrations, and post-approval activities, coordinating cross-functional teams and planning submissions to Health Authorities.

Responsibilities include defining dossier content, guiding regulatory strategy, and representing the function in Health Authority meetings.