Regulatory Affairs Manager
required to provide regulatory drive and expertise during the new product development lifecycle ensuring product approvals are in line with business plan requirements, for our client based in Munster.
Requirements of Regulatory Affairs Manager:
Ensure that the project team's detailed approach is consistent with the agreed regulatory strategy.
Develop and maintain a compliant and highly efficient worldwide regulatory strategy for assigned projects.
Prepare Regulatory documentation e.g. submissions to notified body / regulators for product approval, etc.
Manage communications with regulators during the new product development lifecycle.
Review, provide input and approve development protocols, test reports, labels, promotional materials, etc.
Contribute to the evidence and clinical strategies, including the post market surveillance programme strategy.
Requirements of Regulatory Affairs Manager:
Bachelor's degree is Science or similar applicable technical qualification.
8 years regulatory affairs experience in FDA regulated environment.
Proven compliance experience, particularly for NPI.
Line management or minimum project management experience, to build a team.
Please phone Larry on 01-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
Key words; FDA, GMP, R&D, NPI, Regulatory Affairs, Regulatory Compliance, Manager, Waterford, Cork, Tipperary, Limerick, Kerry, Munster.
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