Our client is a leading Pharmaceutical organisation based in the West of Ireland. The Senior Regulatory Affairs Specialist will be a member of the Research and Development, Regulatory Science group in a well-established team. The role will be very diverse – always something new to learn. Very interesting products -very dynamic. This role will give experience of dealing with health authorities worldwide & working on maintenance projects as well as new projects. It will also involve the person taking leadership on projects under supervisor’s guidance. Full training will be provided as there are both combination products as well as pure pharma products.
The successful person shall be adept at managing multiple demands and multiple priorities to tight deadlines.
• Life cycle management and regulatory filing maintenance activities (Preparation, review and submission of FDA required Annual Reports for Abbreviated New Drug Applications for Mylan Institutional, Preparation, review and submission of amendments and supplements/variations to product marketing applications etc.)
• New Product Submission Activities (Preparation of registration submissions, in eCTD format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required, monitoring the progress of registration submissions, responding to queries etc.)
• Assessment of change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies and submit associated amendments / variations / supplements as required.
• Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.
• Actively participate in project teams, as required
• Research information pertaining to marketing applications for other departments through the navigation of existing submissions and associated comments and regulatory documentation system
• Maintain current knowledge of regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the Health Authority websites and attendance at conferences
• Minimum of a Bachelor's degree (or equivalent) in a science related discipline and 3-5 years’ regulatory experience in the pharmaceutical industry
• A strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidance’s for Industry (particularly those dealing with sterile products)
• Knowledge of the regulatory process pertaining to drug development, registration, review and approval
• Knowledge of parenteral product submissions
• Knowledge of cGMP awareness and compliance
• Experience of writing regulatory submissions, evaluating technical data
• Attention to detail, well organized, work with a certain level of autonomy
• Experience in USFDA
• Experience in new product submissions as well as maintenance
• Change control documentation
• Good communication skills – colleagues internally plus 3rd party manufacturers
• Sterile injectables or Drug-device combination product experience is a plus
• Generic drug industry experience is a plus
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256