Oferta pracy

Regulatory Affairs Consultant With Czech Language

HRK S.A.

  • kujawsko-pomorskie

  • ogłoszenie wygasło 14 dni temu
  • Specjalista (Mid / Regular)

For our Client - an international pharmaceutical company, we are looking for an experienced person for the position:

Regulatory Affairs Consultant with Czech language

Main responsibilities:

  • Manage the Regulatory activities for CEE countries, as delegated by company and in compliance with local regulations
  • Provide regulatory support for company distribution and commercial process
  • Manage regulatory submissions and lifecycle maintenance activities according to company strategy and ensure registration deadlines are met
  • Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority (“HA”) standards and corporate requirements; Ensure that all specific national requirements are met
  • Respond to HAs’ queries and deficiencies in a timely manner
  • Support / Prepare the data needed to make all required registration fees in a timely manner
  • Maintain assigned products' Marketing Authorisations (“MA”) via submission of the appropriate variations and renewals in a timely manner
  • Liaise with company stakeholders to support the timely introduction of new products into markets
  • Notify local HA about marketing / cease of marketing of products and any other regulatory matters as required in the countries within the cluster by the HA
  • Monitor planned approval timelines and if necessary, intervene in order to facilitate approval and minimise registration delays
  • Assist in due diligence process for new business development through audit and review of dossier
  • Provide regulatory input to product lifecycle planning, including building of renewal plans and monitoring and assessing the risk related to “sunset clause” provision
  • Assist with customer complaints handling to ensure they are dealt with efficiently and effectively and in accordance with the technical agreements
  • Assist in recall/quality defect/waiver/out of stock activities as required on behalf of the MA holder and notifications to HAs
  • Implement labelling updates and verify correctness on Pharmaceutical sections. Update product information in national formularies. Organize translation service for PILs to local language
  • Promotions and Marketing – ensure promotional and non-promotional material of medicinal products are compliant with national legal requirements, are available and documented, incl. proof-reading vs current version of the approved local product information and sign off of promo materials, sales force detailing, websites, educational material and in post-marketing studies

Requirements

  • High level education
  • At least 2 years in a similar role in Regulatory Department in the pharmaceutical industry in an international environment
  • Ability to work in a complex matrix team environment and with both internal and external partners
  • Very good English and Czech languages skills

The client offers:

  • Attractive salary plus a bonus system and work tools
  • Work in a global company with top products
  • Dynamic development and work in a competent and committed team
If you are interested in the above offer, please apply by clicking the Apply link, which is tantamount to giving the following consent:
I hereby give consent for my personal data included in my application to be processed for the purposes of the recruitment process and future recruitments under the article 6 paragraph 1 a) of GDPR (General Data Protection Regulation as of 27 April 2016). I acknowledge that HRK S.A. with the registered office in the Warsaw (00-095) is a Data Controller within the meaning of GDPR. I know that I have a right of access, right to rectification, right to erasure (right to be forgotten) or right to restriction of processing. I have also a right to withdraw my consent at any time by sending a appropriate request on: [email protected] My personal data will be processed by Data Controller until the end of all recruitments, unless I withdraw my consent earlier according to familiar procedure.

Ogłoszenie archiwalne