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11894en
- Contract
- English
- Mid-Senior level
- Research & Development
- Bern
- Healthcare & Life Sciences
Skills
Regulatory Affairs, Product Labelling, HAs Submissions
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For our client, one of the leading Healthcare & Life Sciences companies based in the Bern area, Swisslinx is seeking a highly motivated individual to take on a challenging role as Global Regulatory Affairs Labeling Specialist.
Duration: 6 month contract, possibility for Remote work.
Global Product Strategy – Regulatory – Labelling EU
Your mission:
- Generation and maintenance of regional and/or national product labeling texts and mock-ups compliant with current product CCDSs and in accordance with regional or local Health Authority requirements for the assigned Region.
- Timely provision of all required labeling documents needed by the Region for submissions to HAs where product label is affected.
- Implementation of new and updated Company Core Data Sheet's (CCDS's) of the products in the regional/local labeling of the assigned region within the set timeframe.
- Interaction with relevant stakeholders like the CCDS owners, the points of contacts in the region boundaries, and local commercial organizations
- Ensure compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labeling
- Arrange translations of product labeling texts as required and in collaboration with local offices/third parties.
- Maintain labeling databases and systems (PAS, GRDC), as needed.
Your profile:
- University degree or equivalent in a scientific discipline
- Experience in a Global Regulatory Affairs function with knowledge of regulatory product labeling and related processes.
- Competence in documentation practices
- Planning, organizing and time management skills
- Attention to detail
- Understanding of GMP compliance, quality control procedures and documentation practices
- Excellent oral, written and interpersonal communication skills in English
Duration: 6 month contract, possibility for Remote work.
Global Product Strategy – Regulatory – Labelling EU
Your mission:
- Generation and maintenance of regional and/or national product labeling texts and mock-ups compliant with current product CCDSs and in accordance with regional or local Health Authority requirements for the assigned Region.
- Timely provision of all required labeling documents needed by the Region for submissions to HAs where product label is affected.
- Implementation of new and updated Company Core Data Sheet's (CCDS's) of the products in the regional/local labeling of the assigned region within the set timeframe.
- Interaction with relevant stakeholders like the CCDS owners, the points of contacts in the region boundaries, and local commercial organizations
- Ensure compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labeling
- Arrange translations of product labeling texts as required and in collaboration with local offices/third parties.
- Maintain labeling databases and systems (PAS, GRDC), as needed.
Your profile:
- University degree or equivalent in a scientific discipline
- Experience in a Global Regulatory Affairs function with knowledge of regulatory product labeling and related processes.
- Competence in documentation practices
- Planning, organizing and time management skills
- Attention to detail
- Understanding of GMP compliance, quality control procedures and documentation practices
- Excellent oral, written and interpersonal communication skills in English
