Senior Manager Regulatory Affairs

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Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

About the job:

Therefore, the company has taken the decision to establish an international operation to prepare for the commercialization and launch of its assets beyond the US. Madrigal will leverage its International HQ team in Zug to support leadership “on the ground” across Europe & beyond.

Reporting to the Head of Regulatory Affairs International, the (Senior) 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 contribute to developing the company’s International Regulatory Affairs Team, with success measured by accelerating broad access to patients for Madrigal’s innovations, prioritizing the European market first. This role will collaborate closely with the Global Regulatory Affairs team to help implement 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.

Job Title: (Senior) Manager Regulatory Affairs, Region International

Position 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 (Senior) Manager Regulatory Affairs International will be expected to:

• 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 all post-marketing requirements and maintenance activities are met, including product information management
• 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
• Work closely with the Global Regulatory Affairs team to support development and implementation of global regulatory strategy for the company’s products
• Support the International Regulatory Affairs team in contributing various domestic requirements for development and registration on Madrigal’s products
• Support a/o act as the principal liaison with country Competent Authorities for original product approvals and maintenance, including negotiation and maintenance of labelling
• Contribute to the preparation of documents for inclusion in original MAA submissions a/o label extensions; review of key documents related to clinical development and registration of products
• 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
• Support the International Regulatory Affairs team in contributing to global business development opportunities, as applicable

Qualifications and Skills Required:

The ideal candidate displays the following professional competencies

• Profound / Strong scientific and technical skills in order to perform in role
• 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; additional European languages are an asset
• Ability to present clearly using scientific and regulatory terminology
• Sound organizational skills
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions
• Project management skills and focus on delivery of results

Education and professional experience

• Master / Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred)
• Approximately 5-8 years of experience in growing roles in a similar environment in the (bio-)pharmaceutical industry

Additional Information

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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