Regulatory Affairs Project Manager, Submissions – Dublin

Job title:

Company:

Aspen Pharmacare

Job description

Compile country specific regulatory intelligence from Regulatory Affairs Managers responsible for regulatory submission activities in all EU CIS territories and provide the ocnsoldiated interl on the Regulatory Plan to stakeholders from other departments – Pharmacovigilance, Regulatory compliance & Global Regulatory
Provide support in respect to registration strategy (assist in development of regulatory strategy) as well as monitoring the impact of changing regulatory environment on submission strategies
Introduction of the new projects to regulatory submission team
Communicate of the project status to the local affiliates in scope of the project via regular meetings
Coordinate with regulatory submission team the planned submissions ensuring that expectations and objectives are shared on time, documentation required for the submission provided and submission timelines are met
Plan and monitor of submission date per market ensuring that registration deadlines are met, track submission progress through efficient communication to relevant Aspen stakeholders and Regulatory Service Providers (RSPs) and communicate any change in status or delays
Proactively inform the Head of Pharma Affairs Europe CIS and other involved business units regarding all identified risks related to the planned MA applications
Coordinate with Regulatory Compliance the preparation of responses to Request for Information (RFI) received from Health Authorities to achieve the harmonised registered data across the countries

Support / Coordinate the data needed to make all required registration fees in a timely manner
Liaise with other departments to support the timely introduction of new products into markets
Assess the impact on existing registered documentation when new regulatory requirements are issued
Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines.
Ensure information exchange and periodic reporting to the Head of Pharma Affairs Europe CIS – updating and maintaining regulatory submission and RFI tracker on a weekly basis
Monitor planned approval timelines and if necessary, intervene in order to facilitate approval and minimise registration delays
Raise change controls and provide regulatory assessment, strategy and regulatory impact assessment for change controls
Manage the regulatory intelligence updates for the region
Ensure all activities are within the framework of the Aspen QMS
Provide regulatory input for the Annual PQR and PSUR / PBER
Always perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines
Generate Standard Operating Procedures and implement where relevant to the regulatory function
Implement regulatory trainings of all regulatory personnel
Ensure that accurate records are kept and maintained in a secure manner as per Good Documentation Practice; ensure proper data management and archiving

Compile update for Quality Systems Management Review (QSMR) meetings
Monitoring and reporting on regular basis the status of regulatory submissions across the region
Any other duties as assigned by Senior Management

High level education such as BSc, MSc, PhD or Pharmacist in Life sciences or related area
At least 3-5 years in a similar role in Regulatory in the pharmaceutical industry
Proficient English skills