International Regulatory Affairs Specialist

Vor 2 Tagen

Meyrin, Genf, Schweiz OM Pharma Vollzeit

We are recruiting an International Regulatory Affairs Specialist on a 6-month fixed-term contract (maternity leave cover), based at our headquarters and biotech production site in Geneva. Reporting to the Regional Regulatory Affairs Head / International, your mission is to provide operational support to the international Regulatory Affairs team, with a
primary focus on the Middle East and Africa regions
.

Your Main Responsibilities Are As Follows

  • Develop and execute regulatory strategies in collaboration with the line manager, ensuring compliance with applicable guidelines and directives
  • Take ownership of assigned regulatory projects, acting as the main point of contact and ensuring the planning, coordination, and timely execution of all regulatory activities with partner companies
  • Manage submissions for new marketing authorizations and lifecycle maintenance (e.g., variations, extensions) within the assigned territory
  • Collaborate with internal stakeholders (Packaging, Pharmacovigilance, Quality, etc.) to ensure compliance and alignment across projects
  • Represent Regulatory Affairs in cross-functional teams and relevant meetings
  • Maintain accuracy and completeness of entries in the Regulatory Information Management System according to internal guidelines
  • Support business performance improvements by optimizing time-to-market and accelerating product change implementation

To carry out this mission, we are looking for a person with the following profile :

  • University degree in Life Sciences or a related field
  • Minimum of 3 years' experience in international Regulatory Affairs in the pharmaceutical industry; prior exposure to the MEA region is a strong plus
  • Ability to analyze the regulatory requirements and perform comprehensive gap assessments
  • Fluent in English (written and spoken), with good command of French
  • Proficiency in MS Office; familiarity with Veeva Vault desirable

You are a fast-learner, organized and results-oriented professional who thrives in a dynamic environment. Your work is marked by accuracy, proactivity, and the ability to manage tight deadlines while maintaining confidentiality. You also possess strong communication skills, a collaborative mindset, and intercultural competence, enabling you to engage effectively with diverse stakeholders.

Seize this opportunity – apply now and be part of our exciting journey

About Us
OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.

It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.

The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: .

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