Associate Director, Regulatory Strategy

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. 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).

Position Title

Associate Director, Regulatory Strategy

Department

Global Regulatory Affairs

Reports To

VP, Global Regulatory Affairs

Key Responsibilities

• Works on day-to-day regulatory activities of assigned projects for compounds under development and/or marketed. These activities include acting as a regulatory representative on core teams, planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities.
• Actively participates on Project Teams in the development, creation, and implementation of regulatory and development products by providing regulatory guidance and compliance oversight for regulated products.
• Works collaboratively with Project Teams in the development of draft labeling for drug development candidates. Participates on cross-functional teams to establish regulatory strategy for developing content for draft package inserts for NDA/BLA submissions.
• Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies. Develop partnerships both internal and external to the company. Accurately assess and convey regulatory risk/opportunities and influence decision makers.
• Responsible for working on the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, labeling submissions, amendments, and supplements.
• Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.
• Facilitates the regulatory strategy and serves as a Company contact with FDA and ex-US regulatory agencies.
• Liaise with the FDA review divisions and represent Regulatory at FDA meetings (e.g. pre-IND, EOP2, Pre-NDA/BLA) and with global health authorities and development partners as appropriate for their projects.
• Aids in the preparation for meetings conducted with CDER/CBER, including rehearsals and development of meeting requests and briefing books.
• Monitors the regulatory environment and communicates developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc).
• Applies strong technical regulatory knowledge to advising business functions regarding regulatory requirements to enable successful implementation of business strategies.
• Provides expert advice and direction regarding scientific and medical issues as related to application of the FDA and other regulatory requirements for regulated products.

Qualifications

• BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
• Minimum 8-10 years’ branded regulatory pharmaceutical drug development experience. Broad based therapeutic area and product experience.
• Strategic regulatory affairs experience with a proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
• Demonstrated experience supporting and conducting due diligence activities.
• Demonstrated experience interacting with global health authorities.
• Strong knowledge of regulations/guidelines governing global development of pharmaceuticals is required.
• Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies.

Compensation

Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Equal Opportunity Employer

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Agency Submissions

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.