Our client is a leading multinational generic pharmaceutical company, employing over 30,000 people worldwide who strive to provide high-quality medication to their customers. Due to continued growth of the company in Ireland, a role has arisen for a Regulatory Affairs Senior Specialist to be based in their state-of-the-art combination med device and pharma manufacturing facility in the West of Ireland.
As the Regulatory Affairs Senior Specialist, you will be responsible for the management of:
- The company's life cycle management and regulatory filing maintenance activities: author, review and submit requisite annual reports for abbreviated new product applications while reviewing and maintaining amendments, supplements, and variations to product marketing applications.
- New Product Submission Activities: author, review and submit in eCTD format for product approval by US FDA, European/Worldwide Regulatory Authorities, as required while carrying out progress monitoring of submissions of registration.
- The usage of Health Authority regulations, guidance documents, and in-house policies in the assessment of change control documentation and provision of recommendations of the appropriate regulatory reporting mechanism and submission of associated amendments, variations or supplements, as required.
- Liaising with new and existing internal and external partners to facilitate efficient achievement of the company's goals.
- Provision of cross-functional support to the other on-site departments and projects, as required.
- Maintenance of current regulations, requirements, and guidances, utilising Health Authority online resources and attending conferences.
The ideal candidate will have:
- A BSc. or equivalent scientific qualification.
- 3 - 5 years' relevant medical device or pharmaceutical regulatory experience.
- Strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 CFR and various Health Authority Guidances for industry, particularly those dealing with sterile products.
- Experience working with drug development, registration, review and approval and associated regulatory process.
- Parenteral product submissions knowledge desirable.
- Excellent communication skills and the ability to author regulatory submissions and evaluate technical data.
- Well-organised approach to work with an eye for detail and ability to prioritise multiple tasks, adhering to strict timelines.
To discover more about this opportunity, apply now or contact Aidan Toner on +353 91 782 110 for a confidential discussion.