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Regulatory Affairs Specialist
Regulatory affairs, rejestracja, dermocosmetics, dermokosmetyki, life-sciences
Maintaining Product Information Files (PIF) for cosmetic products
Acting as Responsible Person Contact for assigned cosmetic brands
Performing regulatory activities for assigned brands / product categories (cosmetics, medical devices, medicinal products) such as notifications, registrations & post-approval variations
Support the management of the assigned product categories including product name strategy, product information, review of claims, advertising materials, training for sales reps., product pack designs;
Coordination of artworks updates as part of variations submission or other regulatory updates or new product launch and liaison with other functions to manage implementation.
Liaise with authorities responsible for the marketing authorization of concerned products in Poland
Track local and the EU legislation related to authorization and maintenance of authorization for different categories of products.
Reporting safety-related information to Global Safety (via TrackWise or e-mail)
Follow-up with consumers in case of missing information or on request from Global Safety.
Preparing draft answers to medical enquiries.
A scientific degree in chemistry, cosmetology, pharmacy, biotechnology or similar
Minimum 3 years of related experience working with cosmetic products (acting as RP); experience with other product categories (medicines, medical devices) would be of benefit
Very good knowledge of Polish and EU regulations regarding cosmetics, MDs and medicinal products (registration, notification, advertising, distribution etc.)
Fluent English, both written and spoken
Excellent organizational and planning skills
Good communication skills
Possibility of career development
Private medical insurance
Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361. #1172608
28 Feb 2023
Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.
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the specialist consultant managing this position
Hays, ul. Marszałkowska 126/134
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