Director, Regulatory Strategy

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a serious liver disease that can progress to cirrhosis liver failure need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigals 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).

Our success is driven by our people. We are building a dynamic inclusive and high-performing culture that values scientific excellence operational rigor and collaboration. To support our continued growth we are strengthening our workforce strategy to ensure we have the right talent at the right time in the right way.

• Manages the day-to-day regulatory activities of assigned projects for compounds under development

and/or marketed. These activities include acting as the regulatory representative on core teams
developing and 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 submissions.

• Interfaces with various departments within R&D Commercial and other applicable groups to develop

and execute viable Regulatory Strategies. Demonstrate leadership in developing partnerships both
internal and external to the company. Accurately assess and convey regulatory risk/opportunities and
influence decision makers.

• Responsible for managing the compilation submission and maintenance of INDs NDAs MAAs CTAs

amendments and supplements.

• Support and participate in the Companys 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) and with global health authorities and development partners as appropriate for their projects.

• Leads the preparation for meetings conducted with CDER 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 leadership advice and direction regarding scientific and medical issues as related to

application of the FDA and other regulatory requirements for regulated products.

• Deploys Liaison staff to effectively efficiently and collaboratively support business requirements

ensuring regulatory compliance for development and marketed products.
Qualifications:

• BS in life sciences in a healthcare field or equivalent experience advanced degree strongly preferred.

(advanced degree a plus).

• Minimum 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

• Strong preference for candidates to be onsite in either Conshohocken PA or Waltham MA.

Madrigals 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 candidates 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 $XXXXXX - $XXXXXX 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 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.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance please contact

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.

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.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

Please be aware that we have received 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 Madrigals 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.

Please also note that any correspondence with regard to employment would come from an authorized 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 or on behalf of Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to .