This global speciality pharmaceutical organisation are seeking an experienced Regulatory Affairs Project Manager to join the International Submissions team based at their offices in Citywest, Dublin. Reporting to the Head of Regulatory Affairs Europe, this person is responsible for the management and coordination of regulatory operations for the regulatory submission team. Remote working options available.

The Role

Duties and responsibilities of the Regulatory Affairs Project Manager will include but are not limited to:

• Representing the 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
• Provide support in respect to registration as well as monitoring the impact of changing regulatory environment on submission strategies
• Introduction of the new projects to regulatory submission team
• Communicate the project status to the local affiliates in the scope of the project via regular meetings
• Coordinate with the 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 submission date per market ensuring that registration deadlines are met
• Proactively inform the Head of RA (Europe) and other involved business units regarding all identified risks related to the planned MA applications
• Liaise with other departments to support the timely introduction of new products into markets
• Raise change controls and provide regulatory assessment, strategy and regulatory impact assessment for change controls
• Ensure all activities are within the framework of the QMS

The Person

To be considered you will have skills and experience in the following:

• BSc Life sciences or related discipline
• At least 3-5 years in a similar role in Regulatory in the pharmaceutical industry
• Strong submissions experience (EU market knowledge essential)
• Demonstrated project management experience
• Results and performance driven - deliver results that meet or exceed expectations
• Excellent interpersonal and communications skills
• A solutions provider with strong multi-tasking abilities

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.