Regulatory Affairs Labelling Manager

vor 1 Woche


Geneve, Schweiz OM Pharma Ltd. Vollzeit

Location: Meyrin, Geneva, CH- Division:
- Division: Regulatory Affairs- Job Type: Permanent roleIn view of our continued global growth, we are recruiting a** Regulatory Affairs Labelling Manager **at our headquarters and biotech production site in Geneva. Reporting to the Regional Regulatory Affairs Head, your mission is to ensure optimal labelling management and compliance of OM Pharma’s products.

Your main responsibilities are as follows:

- Provide scientific and regulatory labelling input into creation and maintenance of Company Core Data Sheets (CCDS)
- Ensure local labels worldwide are in alignment with CCDS & national requirements and that relevant deviations are documented
- Manage the regulatory labelling database and ensure label related information is made available to stakeholders appropriately (GLS, planning & tracking tools)
- Ensure appropriate communication with affiliates, internal stakeholders and partners to ensure label compliance, including update notifications and maintenance of distribution lists
- Work with product teams to identify and define labelling-related issues
- Coordinate artwork creation and implementation in collaboration with cross functional teams
- Conduct internal trainings and awareness courses on labelling-related topics

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

- University degree in the field of Life Sciences, or similar educational background
- Several years of experience in the pharmaceutical industry, including at least 3 years of experience in drug labelling
- Good knowledge of drug development & labelling related issues
- Fluency in English, both spoken and written, with good command in French (ideally)

You are an experienced team player who enjoys working in a fast paced, hands-on and flexible environment. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with cross-functional and multi-cultural teams. Endowed with an entrepreneurial spirit, you feel comfortable in a position where you make recommendations and take initiatives to move things forward. Finally, you define yourself as a solution-oriented and methodical person who drives novelty.

**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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