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Regulatory Affairs Project Manager (submissions)

Ref: 9221473

  • €55,000 - €65,000
  • 05 May 2020
  • Dublin (West)
  • Perm

Brightwater has been retained in the search for a Regulatory Affairs Project Manager to develop the Management and coordination of regulatory operations for regulatory submission team with decentralised set up.

Key requirements :

• 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 • 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 • 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 in order to facilitate approval and minimise registration delays • Raise change controls and provide regulatory assessment, strategy and regulatory impact assessment for change controls • 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 • 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

Experience required

• 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

Visa Compliance

Due to the urgency of this vacancy, it is not possible for our client at this time to consider anyone without the appropriate work permits, visas or sponsorships already in place. Therefore, we are unable to consider candidates who do not have full authorisation to work in Ireland. Applications submitted without the necessary visa in place will not be considered. To apply for this PV Scientist role, click the “Regulatory Affairs Project Manager” button or for more information, please contact