Regulatory Affairs Specialist with German
Alcon · Warszawa, Poland ·
- Category
- Legal
- Experience
- 5+ years
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
The responsibilities include scientific and administrative activities aimed at ensuring the conditions for the proper marketing of our medical devices and medicinal products. The objective is to ensure that products on the market comply with current pharmaceutical and legal regulations (AMG, HWG, and MPG) and standards, and that corporate policies are adhered to. The role requires independence, initiative, and very good knowledge 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 solutions, viscoelastics, microinvasive surgery, etc.)
- Approval and coordination of the translation process for informational texts (“labeling”), including complex device documentation and packaging material approvals.
- Coordination with the Großostheim affiliate 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 the CCSI 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 based on monthly reports from iMedidata
Clinical investigations – medical devices
- Evaluation and submission of documentation for approval procedures and notifications of clinical investigations to the relevant competent authorities
- Handling of subsequent correspondence 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
- Ensuring accurate product information in compendia such as Rote Liste, Pharmindex, and the self‑medication list
- Regulatory review and approval of promotional materials, as well as verification of advertising claims in accordance with labeling, 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 YOU'LL 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, MPG)
- 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
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