Descripción de la oferta
Regulatory Affairs Expert
Location: Barcelona
Temporary Contract – 6 Months
Salary: €45,000 gross annual salary
⏰ Flexible working hours
International pharmaceutical environment
We are currently looking for aRegulatory Affairs Expertto join a leading international company within the healthcare/pharmaceutical sector.
This is a great opportunity for a regulatory professional looking to grow within a dynamic and collaborative environment with flexible working conditions and international exposure.What We Offer
✨ Flexible working schedule:
Start time between 7:15 am and 9:30 am
Lunch break between 1:00 pm and 3:00 pm
Finish time between 4:00 pm and 7:00 pm
✨ 50% subsidized canteen service
✨ International and collaborative environment
✨ Opportunity to work with global regulatory processes and stakeholdersMain Responsibilities
National registration of new brands, line extensions, and indications.
Maintenance of registered products (translations, variations, RMPs, annual fees, educational materials, databases, etc.).
Ensure product information is properly updated and communicate safety label changes according to internal procedures.
Management of printed packaging materials.
Provide regulatory support to internal stakeholders.
Support licensed and out-licensed products and follow up with licensees.
Interact with AEMPS and other relevant authorities, including access to regulatory databases.
Ensure compliance with training requirements, applicable regulations, quality standards, and company directives.
Conduct regulatory intelligence activities related to guidelines, competitors, and parallel imports.
Support divestments, product pruning, and deregistration activities.
Prepare responses to internal and external requests for product information.
Review promotional materials.
Participate in internal regulatory meetings when required.Requirements
Education
Degree in Pharmacy, Life Sciences, or related scientific field.
Postgraduate qualifications are valued but not mandatory.
Experience
Minimum 2 years of experience in Regulatory Affairs within the pharmaceutical industry.
Skills
Good communication and organizational skills.
Upper-intermediate English level.
Detail-oriented and able to work in a fast-paced environment.
Ability to collaborate with cross-functional teams and external stakeholders.If you are looking for your next challenge in Regulatory Affairs within an international environment, we would love to hear from you!
