Regulatory Affairs Manager

vor 1 Woche

VillarssurGlâne, Freiburg, Schweiz OM Pharma Vollzeit

We are a mid-sized pharmaceutical company based in Fribourg, managing a diverse portfolio of own and partner products. For our Regulatory Affairs Team, we are currently looking for a Regulatory Affairs Manager. Your mission will be to ensure, for the products under your responsibility, compliance with Health Authorities and Quality System requirements. You will play a key role in securing regulatory approvals and maintaining product registrations, contributing directly to the availability of our therapies for patients.

Your Main Responsibilities Are As Follows

  • Develop and implement regulatory strategies for new and existing products
  • Prepare, submit, and maintain regulatory dossiers (MAAs, variations, renewals, etc.)
  • Liaise with Swissmedic and regulatory partners
  • Support cross-functional teams (Quality, Supply, Market Access etc.)
  • Manage all activities related to product labels and Quality system maintenance
  • Monitor competitors' regulatory submissions and authorizations, sharing insights with internal stakeholders
  • Identify opportunities in the regulatory field and proactively support Brand Teams with your expertise

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

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, or equivalent
  • At least 1-2 year of experience in Regulatory Affairs within the Swiss pharmaceutical industry, with proven expertise in regulatory submissions and quality system management
  • Good knowledge of the regulatory environment and direct experience working with Health Authorities
  • Fluent in English and in French or German, with a good working knowledge of the other language
  • Proficient in MS-Office

You are an organized and detail-oriented professional who thrives in dynamic environments. Accuracy, proactivity, and the ability to manage multiple priorities under tight deadlines define your way of working. With strong business acumen and outstanding communication skills, you can effectively collaborate with diverse stakeholders and influence across all levels of the organization. You are willing to contribute to a variety of tasks within a diverse product portfolio.

Ready to make a difference? Apply today and join OM Pharma in Fribourg

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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