Senior Regulatory Affairs Leader - Pharma Compliance

Hollybank Trustees Ltd; Ballymacarbry; On-site; EUR 54,000 - 66,000; Full time

Job summary

Pinewood Healthcare, Ballymacarbry, Co. Waterford, Ireland, is seeking a Regulatory Affairs professional to report to the Regulatory Affairs Manager. The role focuses on renewals, variations and marketing authorisation applications, ensuring compliance across manufacturing.

Educated to life science degree level, TOPRA membership is preferable. The candidate should organise workload effectively, have IT literacy and negotiate with regulatory bodies to support market authorisations.

Qualifications

• Educated to at least degree level in a life science with significant regulatory affairs experience.
• TOPRA membership preferable.
• Ability to organise own workload with minimal supervision.
• Good IT literacy and familiarity with regulatory information systems.
• Ability to present company interests professionally to regulatory bodies.

Responsibilities

• Collate, prepare and progress renewals, variations and marketing authorisation applications.
• Provide regulatory support to manufacturing to ensure regulatory compliance.
• Supervise the administration of the eMC website and EVMPD compliance.
• Coordinate and prepare submission packages for regulatory agencies.
• Interact with regulatory authorities to negotiate favourable marketing authorisations.

Skills

Regulatory affairs

Negotiation

Communication

Independent thinking

Project management

Education

Life science degree

Tools

eMC website

Job description

Pinewood Healthcare, Ballymacarbry, Co. Waterford, Ireland, is seeking a Regulatory Affairs professional to report to the Regulatory Affairs Manager. The role focuses on renewals, variations and marketing authorisation applications, ensuring compliance across manufacturing.

Educated to life science degree level, TOPRA membership is preferable. The candidate should organise workload effectively, have IT literacy and negotiate with regulatory bodies to support market authorisations.