This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. These activities include acting as a regulatory CMC representative on cross-functions teams, planning regulatory CMC submission strategies, and conducting regulatory CMC intelligence activities.
Key Responsibilities- Independently develops and leads execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- Applies expert regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Guides the team in defining and driving the strategy for CMC regulatory dossier content and then reviews this content for conformance with established Health Authority requirements.
- Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related topics.
- Provides global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.
- Proactively identifies regulatory CMC risks, ensuring timely communication with line management.
- Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and emerging trends.
Required & Desired Qualifications- BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
- Minimum of 12 years relevant experience and 8-10 years' regulatory CMC experience, along with broad-based CMC technical and product experience.
- Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life cycle management of small molecule products.
- Demonstrated experience interacting with global health authorities on CMC topics.
- Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals is required.
- Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with technical SMEs at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies
Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $207,000 - $253,000 per year. We comply with all applicable minimum wage laws.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
