Regulatory Affairs Specialist
WarszawaRegulatory Affairs Specialist
Warszawa
NR REF.: 1172608
Main responsibilities:
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.
Warszawa
NR REF.: 1172608
Main responsibilities:
- 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
- Permanent contract
- Working tools
- 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.
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