Our client, a pharmaceutical company in Galway & Dublin are currently looking to recruit a Regulatory Affairs Senior Specialist for their site.
About the role:
- Life cycle management and regulatory filing maintenance activities (Preparation, review and submission of FDA required Annual Reports for Abbreviated New Drug Applications for 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
For further information on this Regulatory Affairs Senior Specialist in Galway & Dublin please contact Bimi Felix on 086 8395533 / email@example.com
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