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, is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. This 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 it for the treatment of compensated MASH cirrhosis (F4c).
About the Role:
We are looking for an experienced and highly organized
Global Submission Senior Manager
with a strong focus on the
European (EU) region
to join our Global Regulatory Affairs team. In this key role, you will lead and manage the planning, compilation, and delivery of high-quality regulatory submissions to health authorities across Europe, while supporting global initiatives.
You will collaborate closely with cross-functional teams including Regulatory Strategy, CMC, Clinical, Labeling, and vendors to ensure submission excellence and compliance with evolving regulatory requirements.
Key Responsibilities:
* Submission Leadership:
Plan, manage, and execute complex regulatory submissions (e.g., MAA, variations, renewals, responses to questions) for EU and associated markets.
* Global Collaboration:
Act as the EU regulatory submissions expert within global submission teams, ensuring alignment with global strategies and timelines.
* Agency Interface Support:
Support interactions with the EMA, national competent authorities, and Health Authorities during the review process.
* Quality Oversight:
Ensure submissions are prepared according to current regulatory standards (eCTD format, IDMP readiness) and company SOPs.
* Timeline Management:
Develop detailed submission plans and track key milestones to ensure on-time delivery of high-quality regulatory dossiers.
* Process Optimization:
Contribute to the development and improvement of global submission processes, templates, and best practices.
* Training and Guidance:
Provide mentorship and guidance to submission coordinators and junior staff, particularly on EU-specific requirements and procedures.
* Regulatory Intelligence:
Monitor and assess changes in European regulatory requirements that impact submission strategies and advise relevant teams accordingly.
Qualifications:
* Bachelor's degree in Life Sciences or a related discipline (advanced degree preferred).
* 7+ years of experience in Regulatory Affairs with a strong focus on regulatory submissions within the EU.
* Solid knowledge of EMA procedures, national requirements (MRP/DCP/CP), and eCTD format.
* Experience managing major submissions (e.g., MAAs, Scientific Advice, Orphan Drug Applications).
* Strong understanding of regulatory operations systems (RIMS, EDMS, publishing platforms).
* Demonstrated ability to lead complex projects and cross-functional teams in a global environment.
* Excellent written and verbal communication skills in English; proficiency in additional European languages is a plus.
* Detail-oriented with strong organizational and project management skills.
What We Offer:
* A dynamic, international environment with opportunities for growth and development.
* A chance to be part of major product submissions and launches across Europe and globally.
* Competitive salary, annual bonus, and a comprehensive benefits package.
* Flexible working arrangements (hybrid).