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Regulatory Affairs Manager

Reference:AMVE-456534 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Regulatory Affairs Manager
Our client, a global pharmaceutical organisation are currently recruiting for a Regulatory Affairs Manager to join their team. This is a permanent opportunity with a growing organisation. As Regulatory Affairs you will be is responsible for both strategic and operational aspects of regulatory affairs objectives for assigned commercial products, life cycle management initiatives and acquisitions.

• Partners in the formulation of regulatory strategies to optimise regulatory timings, competitive positioning and opportunities
• Liaises with the Health Authority responsible for regulatory strategy, tactics and direction to product development in preparation of submission documents and responses to queries by regulatory agencies
• Participate as a team member in developing and implementing a regulatory strategy for highly complex products that balance time, cost, quality and risk
• Provide assistance with regulatory aspects of marketed product life cycle management including critical issue management and major line extensions
• Work with the Regulatory Affairs team to create regulatory strategies for presentation to internal governance bodies
• Influence internal and external customers as necessary to ensure successful strategy implementation
• Provide interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations
• Ensure quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and Standard Operating Procedures

• Bachelor’s degree in Life Sciences, Chemistry or Biology. A postgraduate degree is advantageous
• 5-8 years previous biotechnology and/or pharmaceutical drug development experience
• 5 years regulatory affairs experience preferably involving direct contact with regulatory agencies
• Knowledge of EU Regulations and guidelines
• Knowledge of FDA & ICH regulations and guidelines is advantageous.
• Working knowledge of dossier requirements New Drug Application (NDA), Marketing Authorisation Application (MAA) and Clinical Trial Authorisation (IND, IMPD, CTA)
If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252