Regulatory Affairs Manager

vor 2 Wochen

VillarssurGlâne, Schweiz OM Pharma Ltd. Vollzeit

Location: Villars-sur-Glâne, Fribourg, CH
- Division:

- Division: Regulatory Affairs
- Job Type: Permanent role

For our Swiss Affiliate in Fribourg, we are currently looking for a Regulatory Affairs Manager to join our team. 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:

- Ensure compliance of OM Pharma Switzerland (OMCH) products with all relevant regulations and Health Authorities' requirements
- Prepare, submit and follow up on regulatory documents to obtain and maintain product registrations and licenses
- Manage all activities related to product labels and Quality system maintenance
- Act as a key contact with Health Authorities and relevant institutions, ensuring constructive and trusted relationships
- 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, French and/or German, or at least a good knowledge of the other national language (spoken and written)
- 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.

**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.

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