Cache of job #13890290

Job Title

Regulatory Affairs Associate

Employer

Pe Global

Location

Dublin South

Description

Responsibilities. Supporting regulatory activities for new marketing authorisation applications and product launches. Maintenance of marketing authorisations working via a range of regulatory activities including submission of variation applications across all aspects of registered particulars. Managing deletions and divestitures as required, quality issues and MA renewals. Working with the HPRA to support review and obtain timely approval for changes. Implementation and communication of MA changes. Ensuring all compliance activities are correctly managed. Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, that are in line with regulatory requirements and company approval systems. Maintaining a sound knowledge of European and Irish regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to our products. Taking part in local regulatory activities and working with the EU regulatory office to support products registered through European procedures. Utilising and supporting company compliance systems in relation to product responsibilities. Making constructive contributions to departmental issues and projects. Education and Experience. Third level degree in Life Sciences or Pharmaceutical. At least 2 years’ experience within regulatory procedures and requirements with an understanding of EU and Irish Medicines Legislation. Able to work to challenging deadlines and manage conflicting priorities. Excellent verbal and written communication skills, with the ability to interact with a wide range of people both internal and external including the regulatory agency. Interested candidates should submit an updated CV. Please click the link below to apply, call Emma on 0214297900 or alternatively send an up to date CV emma.okeeffe@peglobal.net. This job originally appeared on RecruitIreland.com.

Date Added

2164 days ago

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