Key Responsibilities.
- Management and coordination of regulatory operations for regulatory submission team with decentralised set up
- Representing regulatory submission function in the projects related to the operational changes, technical projects or the projects driven by PV department
- Compile country specific regulatory intelligence from Regulatory Affairs Managers responsible for regulatory submission activities in all EU CIS territories and provide the consolidated intel on the Regulatory Plan to the 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 stakeholders and Regulatory Service Providers (RSPs) and communicate any change in status or delays
- Proactively inform the Head of RA (Europe) 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
- Manage the Commitment Tracker
- 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 RA (Europe) – updating and maintaining regulatory submission and RFI tracker on a weekly basis
- Monitor planned approval timelines and if necessary, intervene 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
Education/Requirements:
- 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
- Positive ‘can – do’ attitude
- Be able to work autonomously and have good problem-solving skills
- Able to cope with evolving deadlines effectively with regular feedback and updates.
- Honest and trustworthy
- Act with integrity
- Respectful and highly personable
- Possess cultural awareness and sensitivity
- Flexibility & Confidentiality are key requirements for this role.
Thornshaw is a division of the CPL group www.thornshaw.com
