Regulatory Operations Specialist

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About the client:

We are seeking a Regulatory Operations Specialist to join one of our clients in the pharmaceutical sector. The position is based in Barcelona and offers a hybrid work model.

Your mission:

As the Regulatory Operations Specialist you will support our Regulatory Affairs department by contributing to the analysis and reporting of regulatory data. As part of the transition to a unified platform this position will ensure consistent recording and use of regulatory data as well as the execution of reporting activities. The role reports to Corporate Head of Regulatory Affairs.

Your major accountabilities:

In close collaboration with our Corporate RA team and Countries RA teams:

• Implementing our RIM & DMS project as per the agreed timelines in liaison with our chosen external provider.

• Contributing with IT team on RA projects requiring data analysis or data migration as needed.

• Managing electronic document management systems to ensure compliance and accessibility of regulatory documents.

• Providing support and guidance on regulatory operations processes to internal & external stakeholders.

• Managing Pharmacopoeia updates: BP EP & USP.

• Staying up to date with the updates in PLM IDMP XEVMPD (new compulsory fields).

• Reviewing & assessing the integration of the local RA folders in each affiliate (local folders vs Corporate folders).

• Collaborating with cross-functional teams to ensure timely completion of regulatory deliverables.

• Continuously monitoring and optimizing regulatory operations processes to improve efficiency and compliance.

• Identifying discrepancies and possible alignments between different systems.

• Ensuring compliance with the regulatory requirements related to our RA platforms & databases and providing regulatory intelligence to support strategic decision making (new HAs requirements).

• Proposing process/system improvements to better align/use data for RA activities.

• Establishing measures/KPIs to improve data quality efficiency and compliance.

• Collaborating with relevant RA teams quality and other departments to ensure alignment & compliance.

• Updating our internal SOPs related to Reg Operations activities.

• Liaising with Countries RA teams to keep the RA department updated with relevant changes in Agencies portals (including relevant webinars from EMA/CHMP/HAs).

We would like you to have:

• Bachelors degree in a scientific or related field; advanced degree preferred.

• Background in Pharmaceutical Companies in a similar Regulatory Operations role.

• Minimum of 5 to 7 years of experience in Regulatory Affairs.

• Proficiency in electronic document management systems (eg eCTD) and regulatory submission software.

• Be a data-driven professional who thrives working with IT systems & databases.

• RIMS (Regulatory Information Management System) knowledge and Reporting tools are preferred.

• Excellent organizational communication and problem-solving skills.

• Fluent in English.