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Vice President, Regulatory Affairs, CMC
- Conshohocken, Pennsylvania, United States
- Conshohocken, Pennsylvania, United States
Über
Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).
Key Accountabilities Business Operations
Act or assign a regulatory representative for each project team.
Oversee the development and implementation of regulatory submission strategy.
Manage the planning, preparation and technical review of regulatory submissions and ensure submissions are completed to meet required/established timelines.
Collaborate on the development and optimization of product development strategy to be consistent with regulatory requirements.
Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions.
Business Strategy
Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.
Provide regulatory guidance and strategy for life-cycle management planning and development for commercial products.
Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes.
Compliance
Ensure regulatory conformance for commercial products through effective change management.
Fiscal Discipline
Manage budget associated with group activities including submission fees (ex-US), business travel and training.
Due Diligence
Provide regulatory support for due diligence activities associated with the assessment of business opportunities.
Qualifications Education & Experience
+20 years of overall relevant experience.
Graduate degree in a scientific/technical discipline (Ph.D., MS Science or PharmD) with a minimum 12 years pharmaceutical drug development experience and 7 years hands‑on regulatory experience.
Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals.
Basic computer skills (MS Office, Excel and Adobe Acrobat).
Experience supporting and conducting due diligence activities.
Knowledge
Strong knowledge of regulations/guidelines governing pharmaceutical/biologics development is required.
Familiarity/understanding of FDA regulatory processes; experience with ex‑US regulatory authorities/processes is required.
Skills & Abilities
Ability to communicate clearly and concisely with senior management and regulatory authorities.
Ability to multitask in a fast‑paced environment with multiple/changing priorities.
Experience managing multiple headcount and developing/mentoring junior staff.
Ability to effectively delegate tasks and hold others accountable.
Physical Requirements
Occasional business travel.
Compensation and Benefits Madrigal’s total rewards strategy includes base salary, bonus, equity, comprehensive benefits and a 401(k) plan. The base salary range for this position is $315,000 to $386,000 per year. All employees receive equity and are eligible for flexible paid time off, medical, dental, vision and life/disability insurance, as well as optional voluntary benefits such as supplemental life insurance and legal services.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need.
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Sprachkenntnisse
- English
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