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.
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).
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.
This position is ideal for mid-level regulatory professionals to join the Regulatory Operations team as Senior Manager, Ad Promo & Labeling, managing key regulatory processes and ensuring compliance across global markets for advertisements and promotional materials and labeling. Partnering with cross-functional teams, you'll provide expert regulatory insights and support to ensure compliant product launches and maintain regulatory standards throughout the product lifecycle. This role is crucial in maintaining Madrigal’s regulatory compliance and supporting successful regulatory operations globally.
Key Responsibilities
Ad Promo & Labeling Submission Support
Act as the point of contact for all advertisements and promotional material assets, globally and in North America.
Access and manage the regulatory assets.
Assist with the review, remediation, and/or implementation of regulatory processes.
Review marketing advertisements and promotions for regulatory compliance within the marketing material review platform as systems SME and provide guidance and training on processes as required.
Provide guidance on regulatory requirements for processes for creating marketing materials.
Maintain and update Global regulatory requirements labeling reference document.
Ensure labeling practices comply with regulatory standards, performing impact and gap assessments for new or revised requirements.
Support the preparation, tracking, submission, and archival of regulatory documents for Ad Promo and labeling.
Regulatory Operations Support
Oversee the use of wizards, templates, and structured content within systems to ensure consistent data entry and record creation. Manage email notification, renditions, jobs and vault loader.
Collaborate with cross-functional teams (internal and external) to ensure regulatory compliance across all operations.
Provide training and support to team members on regulatory requirements and best practices.
Third party vendor oversight.
Compliance & Inspection Readiness
Maintain operational documentation.
Maintain up-to-date knowledge of global regulatory standards and requirements.
Participate in internal and external audits, providing necessary documentation and support.
Contribute to continuous improvement initiatives within the regulatory strategy and operations team.
Provide additional support as required.
Requirements
Minimum of a Bachelor's degree in a technical or life sciences field.
7+ years of experience in quality or regulatory roles in a regulated industry
Experience with Veeva RIM and PromoMats is a plus.
Experience with project management is a plus.
Excellent presentation and communication skills both virtually and in-person.
Ability to work both independently and collaboratively in a global team.
Some office travel may be required.
Nice-to-haves
Strong critical thinking and problem-solving abilities.
Attention to detail.
Excellent organizational skills.
Proficiency in managing multiple tasks and prioritizing effectively.
Expertise in labeling and labeling change assessments.
Strong technical/computer skills.
Outstanding written and verbal communication skills, with the ability to effectively communicate at multiple levels in the organization.
Ability to collaborate across cross-functional teams.
Independence and self-direction, with a strong desire to work collaboratively as part of a high-performing team.
Adaptable and flexible in a fast-paced environment.
Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package. Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
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 $159,000- $195,000 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.
We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [email protected].
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 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.
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 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 [email protected].
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What We Do
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist that is designed to target key underlying causes of NASH in the liver. Resmetirom is currently being evaluated in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits in patients with NASH. For more information, visit www.madrigalpharma.com
