Regulatory Affairs Specialist with German
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Job Summary
The responsibilities include scientific and administrative activities aimed at ensuring the conditions for the proper marketing of our medical devices and medicinal products. Theobjectiveis to ensure that products on the marketcomply withcurrent pharmaceutical and legal regulations (AMG HWG and MPDG MDR) and standards and that corporate policies are adhered to. The role requires independence initiative andvery goodknowledge of pharmaceutical and medical device law.
In this role a typical day will include:
Management of medical devices (Vision Care: contact lenses and care solutions; Ophthalmic Surgery: visualization equipment irrigation solutionsviscoelastics microinvasive surgery etc.)
- Approval and coordination of the translation process for informational texts (labeling) including complex device documentation and packaging material approvals.
- Coordination with theVision Careaffiliate Aschaffenburg for all product-related activities.
- Support and lifecycle management of our medicinal products in particular:
- Preparation and submission of variations marketing authorization renewals and PSURs
- Review of chemical-pharmaceutical topics and documentation as well as
- Handling the resulting variation submissions
- Revision of packaging texts including patient information leaflets and summaries of product characteristics
- In the case of product changes or discontinuations cost-conscious coordination of packaging material stock depletion and product inventory sell-off timelines
- Coordination of safety labeling update process: tracking and ensuring the implementation of safety-relevant information in the labeling texts of all products marketed in Germany. Monitoring compliance with KPIs as applicable.
Clinicalinvestigationsmedicaldevices
- Evaluation and submission of documentation for approval procedures and notifications of clinical investigations to the relevant competent authorities
- Handling ofsubsequentcorrespondence and deficiency letters
- Submission of amendments and notifications of study termination including submission of final reports
- Review and approval of labeling drafts for clinical investigational samples
Marketing Support
- Ensuringaccurateproduct information in compendia such asRoteListePharmindex and theselfmedicationlist
- Regulatory review and approval of promotional materials as well as verification of advertising claimsin accordance withlabeling HWG and UWG
- Handling regulatory and scientific inquiries including customer requests
- Providing legal support for marketing projects
- Monitoring and interpreting legal requirements and official communications related to medicinal products medical devices food supplements and cosmetics.Initiating resulting measures and implementing new processes.
WHAT YOULL BRING TO ALCON:
- Bachelor Degree (best in Pharmacy) and 5 years of relevant experience.
- Fluent English and German - min. B2
- Good knowledge of regulatory requirements (AMG HWG MDR MPDG)
- Solid pharmaceutical knowledge (marketing authorization dossier)
- Very good computer skills (MS Office)
HOW YOU CAN THRIVE AT ALCON:
- Opportunity to expand knowledge and experience in the field of regulatory affairs.
- Friendly working environment and a diverse and highly motivated team
- Very best working environment for our employees Alcon Polska has been recognized as a Top Employer for the two years in a row
- Truly international environment and daily interactions with colleagues and stakeholders from all over the world
- Attractive benefits package (private medical care group insurance lunch card transportation allowance pension plan Multisport/cultural card Alcon products for you and your significant other)
- Moderrn office with a lot of facilities inside located at NewCity building 15 Marynarska Street Warsaw
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
Required Experience:
IC
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
