- Preparation, review and submission of supplements to existing approvals (with guidance from Senior Regulatory personnel).
- Support Lead Specialist/Regulatory Management in monitoring the progress of regulatory submissions, responding to queries and ensuring that approvals are granted without undue delays.
- Preparation, review and submission of Annual Reports for ANDAs/NDAs. This also includes the review of documents, utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements.
- Assess and review documentation to ensure compliance with product licenses.
New Product Submission Activities:
Preparation of registration submissions, in CTD format, for approval by the US FDA, European Regulatory Authorities and worldwide, as required (with guidance from Lead Regulatory Specialist/Regulatory Management). Support monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
Make updates to departmental procedures to foster an environment of continuous improvement.
Administrative support in the preparation of regulatory documentation for global submissions (hard copy and electronically), communicate submission schedule to e-submission group and perform quality checks on documentation at the time of submission of dossiers. This includes filing, archiving, photocopying and scanning of regulatory documentation. Perform literature searches and order publications from libraries.
Coordinate regulatory activities, this includes scheduling meetings, preparing presentations, conference calls set up and record minutes, management of regulatory information systems, i.e. excel spreadsheets, databases, web-based document management systems (Microsoft SharePoint).
- A minimum of a bachelor’s degree (or equivalent) in a science related discipline and 1-2 years regulatory experience in the pharmaceutical industry.
- Topra certification or RAC, preferred.
- Knowledge of the Ph.Eur, USP, 21 CFR and various FDA Guidance’s for Industry
- Knowledge of cGMP awareness and compliance.
- Knowledge of sterile products and their regulatory requirements.
- Strong working knowledge of databases, Microsoft Office Suite, Lotus Notes (email) and knowledge of Adobe. Confidentiality of departmental and company business is essential.
- Proficiency in speaking, comprehending, reading and writing English is required.
For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email firstname.lastname@example.org.
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie