Regulatory Affairs Spain en Madrid , España

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