Regulatory Operations Specialist at Actual Talent

Barcelona, Catalonia, Spain -

Full Time

Start Date

Immediate

Expiry Date

27 Apr, 26

Salary

0.0

Posted On

27 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Data Analysis, Document Management, Compliance, Pharmaceuticals, Communication, Problem Solving, IT Systems, Data Migration, Regulatory Intelligence, Process Improvement, Collaboration, Project Management, KPI Development, SOP Development, Regulatory Submissions

Industry

Staffing and Recruiting

Description

Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology. 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: Bachelor's 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.

Responsibilities

The Regulatory Operations Specialist will support the Regulatory Affairs department by analyzing and reporting regulatory data, ensuring consistent recording and execution of reporting activities. The role involves collaboration with various teams to optimize regulatory operations processes and ensure compliance with regulatory requirements.