Junior Regulatory Affairs Specialist

Main Purpose:

To undertake regulatory tasks to support the Consumer Health Regulatory Team in Iberia (Spain & Portugal) including but not limited to:

1. Post-approval activities and regulatory submissions for medicines, medical devices, food supplements and cosmetics

2. Overall management and technical support of Regulatory databases.

3. Supporting role in the financial tracking and recording within respective systems/documents

4. Responsibility in preparation and implementation of artworks with regards to management of internal systems

5. Management of translations of text and artwork as appropriate

6. 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

1. 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.

2. Management of all Regulatory trackers/databases

3. Management of artwork generation & implementation in respective internal systems.

4. Notifying authority of end of commercialisations

5. 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.

6. Proofing of regulatory documents as required, including management of any translations.

7. Supporting the monitoring of Iberia RA budget including raising requisitions and processing invoices/payments of fees when required

8. Ensure compliance with EU regulatory requirements, codes of practice, global SOPs and internal guidelines.

9. Filing and archiving of authority correspondence (e.g., authority confirmation emails, approval letters, RFI responses) in appropriate product variation folders and databases.

10. Supporting post-approval actions both internal (e.g., artwork updates, SmPC/PIL updates, HA/local medicines database updates, compliance checks on artwork)

11. 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