Responsible for performing, reviewing and approving local regulatory affairs activities, with especial focus in the Spain registration process for vaccine medicines (Orden Ministerial SND/778/2023).
Client Details
International Pharmaceutical Company
Description
* Ensure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.
* Work with internal & external customers to provide data and accurate regulatory input.
* Prepare & review labelling/Packaging texts and information brochures and communication activities.
* Run regulatory local projects meeting timelines and costs
* Understand relevant legislative and regulatory guidance applicable to activities of the company
* Prepare risk benefit analysis
* Active involvement in concepts of regulatory strategy
* Attend industry and RA meetings
* Communicating with local regulatory agencies and document communication
* Provide local RA support to local Sales, Customer Services, QA, LSO, Medical and Marketing depts.
* Prepare and update local SOPs
Profile
* Life sciences degree related to the activity Minimum of 4 years in the regulatory pharmaceutical field (preferred experience with biological products)
* Demonstrated ability to write good quality documents
* Highly PC literate
* Project management abilities
* Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
* Fluency in English language
Job Offer
* Flexible hybrid model (up to 4 days home office), during trial period non applicable.
* Flexible shift
* Madrid (Alcalá Henares) or Barcelona (St Joan dEspi)
* Social benefits
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