My client, a global pharmaceutical company in Southwest Dublin, is currently recruiting for a Regulatory Affairs Project Manager to join their team.
This is a maternity contract (13 months) and will report to the Head of Regulatory Affairs Europe.
Hybrid working available (2 days onsite)
· 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.
Essential Experience & Education 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.
· The person must have EU regulatory submission experience and submissions with generic pharmaceutical products
· Proficient English skills
· Results and performance driven – deliver results that meet or exceed expectations
· Accountability and ownership – deciding and initiating actions
If you are interested in applying for this role or discuss the position in more detail, please call Zoe on +353 1 2784671 or email [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com