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15063en
- Contract
- English
- Associate
- Legal, Regulatory & Compliance
- Bern
- Healthcare & Life Sciences
Skills
Regulatory Affairs, Submission Package, Indication Submission, Variations, Renewals, GRA, Registration of products
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This vacancy has now expired
On behalf of our client, an international Biotechnology company based in Bern, Swisslinx is looking for a Regulatory Affairs Specialist to support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU)).
This is a 12-months contract position (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
- Start date: 01/05/2023
- Duration: 12 months
- Extension: possible
- Workload: 100%
Your mission:
- Monitor local regulatory activities to ensure business objectives and timely implementation
- Be responsible for a specific submission package (new product/indication submission, variations, renewal) from preparation to submission in the region, by coordinating the preparation of the modules with the appropriate stakeholders
- Interact with Global Labelling relating to the labeling activities in the Region
- Support for the overall coordination and dispatch of responses to Health Authority questions, which include:
- Preparing answers for simple questions not requiring product expertise or input from other internal stakeholders
- Supporting internal stakeholders for the strategy, planning and preparation of response for complex scientific questions requiring product expertise
Your Profile:
- A degree in Biological or Medical Science or Pharmacy or equivalent
- At least 3 years professional experience in Regulatory Affairs within international markets
- Good communication skills
- Fluent in English and any other language as Spanish, French, Arabic, Russian is an advantage
To apply or for any further information, please do not hesitate to contact Alina Peeva, senior recruiter: alina.peeva@swisslinx.com or press "apply now" below
This is a 12-months contract position (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
- Start date: 01/05/2023
- Duration: 12 months
- Extension: possible
- Workload: 100%
Your mission:
- Monitor local regulatory activities to ensure business objectives and timely implementation
- Be responsible for a specific submission package (new product/indication submission, variations, renewal) from preparation to submission in the region, by coordinating the preparation of the modules with the appropriate stakeholders
- Interact with Global Labelling relating to the labeling activities in the Region
- Support for the overall coordination and dispatch of responses to Health Authority questions, which include:
- Preparing answers for simple questions not requiring product expertise or input from other internal stakeholders
- Supporting internal stakeholders for the strategy, planning and preparation of response for complex scientific questions requiring product expertise
Your Profile:
- A degree in Biological or Medical Science or Pharmacy or equivalent
- At least 3 years professional experience in Regulatory Affairs within international markets
- Good communication skills
- Fluent in English and any other language as Spanish, French, Arabic, Russian is an advantage
To apply or for any further information, please do not hesitate to contact Alina Peeva, senior recruiter: alina.peeva@swisslinx.com or press "apply now" below
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