Company: Brightwater
Location: Tipperary

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Tipperary

Permanent

A key client in Tipperary has a vacancy, initially to cover a Maternity Leave contract, for an experienced Regulatory Affairs Specialist with a background in the Pharma or Medical Device industry and experience in managing Projects,
Working in a supportive and flexible environment you will provide RA support to an exciting project. There will be options to perform some of the work from home if required.
About the Job:
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
• Review the preparation of CMC components for filings and assess fitness of purpose for submission in the relevant countries
• Gathering, consolidating and analyzing regulatory intelligence for the EU & ROW territories and support its application to product-specific activities
• Ownership/ regulatory responsibility for a portfolio of products for nominated client; via a range of regulatory activities including submission of new marketing authorization applications, variation applications and renewals.
• Work with the Managing Director and Project Manager to ensure that client deadlines are met and that appropriate resources are allocated to the various projects
• Maintain communication with client and Acorn Regulatory teams to ensure that projects are delivered in keeping with our responsibilities to the client.
• Builds and maintains strong relationships with EU competent authorities to ensure ease of access & influence.
• Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to the company’s products.
• Supports EU regulatory initiatives and issues as appropriate.
About You:
• BSc (MSc or higher preferred) life sciences, or related field
• 7-10 years related experience within Pharmaceutical Regulatory Affairs
• Experience with global legislation and regulations relating to medicinal product registration
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, line extensions and renewals.
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Ability to project manage across a diverse and complex portfolio of products and priorities.
For more on the role call Nigel on 021 4221000 or send your CV for consideration.