Main Purpose:
To undertake regulatory tasks to support the Consumer Health Regulatory Team in Iberia (Spain & Portugal) including but not limited to:
- Post-approval activities and regulatory submissions for medicines, medical devices, food supplements and cosmetics
- Overall management and technical support of Regulatory databases.
- Supporting role in the financial tracking and recording within respective systems/documents
- Responsibility in preparation and implementation of artworks with regards to management of internal systems
- Management of translations of text and artwork as appropriate
- Support with advertising materials revision
Main Working Relationships:
Iberia/EUN/Global Regulatory Teams
Iberia Business e.g. Medical Information, Procurement, IT, legal, sales, marketing, trade marketing, quality, supply...
External Health authorities and other competent authorities
Industry associations
Key Tasks/Responsibilities
- Management of submissions to the authority, including variations, renewals, notifications and other regulatory submissions as required for a portfolio that includes Medicines, Medical Devices, Food Supplements and Cosmetics.
- Management of all Regulatory trackers/databases
- Management of artwork generation & implementation in respective internal systems.
- Notifying authority of end of commercialisations
- To undertake special projects (e.g. regulatory intelligence, competitor information, tracking new legislation, submission support) and support regulatory team as needed for internal and external meetings.
- Proofing of regulatory documents as required, including management of any translations.
- Supporting the monitoring of Iberia RA budget including raising requisitions and processing invoices/payments of fees when required
- Ensure compliance with EU regulatory requirements, codes of practice, global SOPs and internal guidelines.
- Filing and archiving of authority correspondence (e.g., authority confirmation emails, approval letters, RFI responses) in appropriate product variation folders and databases.
- Supporting post-approval actions both internal (e.g., artwork updates, SmPC/PIL updates, HA/local medicines database updates, compliance checks on artwork)
- Support with the revision of advertising materials and obtain external validations, if applicable.
Skills & qualifications:
- Education: Science degree (Pharmaceutical sciences preferred)
- Excellent knowledge of IT in order to work with databases and to prepare high quality documents
- Ability to work in a team
- Ability to organise and plan effectively with good communication skills
- Commercial awareness and good information management skills
- Customer focus and proactivity
- Good commercial awareness
- Ability to organize and plan effectively
- Fluent in Portuguese and English. Working knowledge of Spanish is desired but not mandatory
Application Period: 5/06/2026 - 22/06/2026 Reference Code: 872591
Division: Consumer Health Location: Portugal : Estremadura : Carnaxide
Functional Area: Regulatory Affairs Position Grade: 08
Employment Type: Regular Work Time: Regular
Contact Us
Address Telephone E-Mail
Rua Quinta do Pinheiro, 5 [email protected]