Regulatory Affairs Specialist APAC - Limited Contract (6 months) - Geneva
Key information
Publication date:
03 July 2024Workload:
100%Contract type:
Temporary-
Place of work:
Genève
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: ompharma.com.
To cover a maternity leave within our Regulatory Affairs Team, we are recruiting a Regulatory Affairs Specialist APAC based at our headquarters in Geneva, for a 6-months limited contract starting ideally in September 2024. Reporting to the Regional Regulatory Affairs Head / International, your mission is to participate in the definition and execute regulatory strategies based on appropriate interpretation of guidelines and directives, with the particular focus on APAC legislation developments.
Your main responsibilities are as follows:
- Act as Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of OM Pharma and corporate or regional stakeholders
- Maintain the assigned Regulatory Data Base Entries in Regulatory Information Management System according to internal guidelines
- Keep oversight on all regulatory actions in the APAC region
- Clarify requirements for planned regulatory activities
- Manage the response to Health Authority questions / requests for information
- Support Health Authority inspections and partner audit inspections
- Supply partner companies with required regulatory documents
- Support internal regulatory work flows and processes improvement
- Ensure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Regulatory Affairs such as the EU/US/CH, Labelling, RegOps and CMC
- Keeps up to date with the latest regulatory requirements with the focus on the regulatory strategy in APAC
- Manage successfully assigned regulatory projects
To carry out this mission, we are looking for a person with the following profile:
- Educational background the field of Life Sciences
- 3 years of experience in international Regulatory Affairs within the pharmaceutical industry, with, ideally, previous experience in APAC region
- Full fluency in English; bringing additional French skills would be an asset
You describe yourself as an organized and result-oriented person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to deal with tight deadlines. You also demonstrate strong communication skills, a good team spirit and intercultural competencies, which allows you to interact efficiently with various stakeholders.
Are you interested in this opportunity? Apply as soon as possible and join OM Pharma!
Contact
- Service Recruiting