Regulatory Affairs Specialist

Regulatory affairs, rejestracja, dermocosmetics, dermokosmetyki, life-sciences
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.
Requirements:
  • 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
We offer:
  • 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. #1172608
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Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Warszawa
Specialism
Pharma
Ref:
1172608
Closing date
28 Feb 2023

Talk to a consultant

Talk to Aleksandra Figielska, the specialist consultant managing this position, located in Warszawa
Hays, ul. Marszałkowska 126/134

Telephone: 722000702

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