Senior Regulatory Affairs Specialist

JOB DESCRIPTION

Senior Regulatory Affairs Specialist

Duration: 12 Months

Location: Galway

Responsibilities:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower-level professionals.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies.

Education & Experience:

• Requires a University Degree and minimum of 4 years of relevant experience
• Project management experience
• Works independently with general supervision on larger, moderately complex projects / assignments.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***