For our Client - an international pharmaceutical company, we are looking for an experienced person for the position:
Regulatory Affairs Consultant with Czech languageMiejsce pracy: Warszawa
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
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
