Senior Manager International Regulatory Affairs - #44260

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.

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.

Reporting to the Head of Regulatory Affairs International, the Sr. Manager Regulatory Affairs International is a crucial hire for the success of the company’s worldwide ambitions.

Madrigal is seeking to appoint a Regulatory Affairs professional who can efficiently and effectively support the International Regulatory Affairs Team, with success measured by implementing and driving strong operational execution. This role will collaborate closely with the International Regional Regulatory Leads and Global Regulatory Operations team to help support the international strategies effectively.

This is a challenging position, offering the opportunity to contribute to the development and success of a truly innovative biopharmaceutical company committed to making a difference in the lives of patients.

Key Responsibilities

This is an outstanding opportunity to contribute to the development and success of Madrigal Pharmaceuticals as it builds its presence in Europe and beyond. Specifically, the Sr. Manager Regulatory Affairs International will be expected to:

• Support all Regional Regulatory leads / operational execution
• submission planning,
• submission building,
• submission execution in liaison with established external service providers
• Become the International Regulatory Affairs representative and point person for the Regulatory Information Management System (and other systems the organization implements and where regulatory input is required, e.g. artwork management systems)
• Serve as the International Regulatory Affairs point person for Budget and Finance activities
• Support building the regulatory infrastructure to ensure regulatory support in various countries
• Contribute to regulatory-related launch and post-marketing activities in the EU
• Ensure product information is maintained in national databases
• Ensure all packaging and labelling requirements are met according to local requirements
• Ensure promotional / disease awareness and internal training materials, as applicable, meet the requirements of the applicable EU Directives and national regulations
• Contribute to supporting the partner market environment
• Support the International RA team in contributing various domestic requirements for development and registration on Madrigal’s products
• Contribute to the preparation of documents for inclusion in original MAA submissions a/o label extensions or other post-marketing lifecycle activities
• Ensure regulatory compliance within scope of role
• Keep abreast of regulatory requirements and anticipating their future impact on Madrigal within scope of role
• Contribute to annual budget and operate within that budget
  

Profile

The ideal candidate displays the following professional competencies

• Profound / Strong technical skills in order to perform in role, with a special focus on Regulatory Information Management Systems
• Strong interpersonal capabilities and ability to build and maintain networks
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and technical writing skills
• Fluent in English language a must, in German preferred; additional European languages are an asset
• Ability to present clearly using scientific and regulatory terminology
• Sound organizational skills and strong understanding of operational execution
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions
• Project management skills and focus on delivery of results
  
  

Qualifications

• Master / Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred)
• Approximately 4-6 years of experience in growing roles in a similar environment in the (bio-)pharmaceutical industry
  
  

We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.

Please note that this job description is not exhaustive and may evolve over time. Only shortlisted candidates will be contacted. Applicants must be authorized to work in the country of employment at the time of application. Employment terms, where applicable, will be governed by relevant collective bargaining agreements.

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.