A globally recognised healthcare organisation specialist in high volume manufacture and production of topical and solid dose products are seeking to appoint a Regulatory Affairs professional to join their Regulatory Affairs team.
The Role
Reporting to the Senior Regulatory Affairs Team Lead, you will act as Project Manager to facilitate the delivery of submissions within a specific product portfolio. You will be monitoring performance progress and communicating such with relevant stakeholders. In addition, you will also be responsible for:
- Life cycle management to ensure sufficient pipeline
- Authoring and reviewing module 1 documentation
- Governing repsonses to health authority queries and deadlines
- Ensuring specific management systems are up to date in accordance with quality and compliance standards
The Person
The ideal candidate will:
- Be degree qualified in a relevant discipline
- Have 3+ years' working experience within regulatory affairs
- Possess knowledge of submission strategies
For more information about this opportunity apply online or contact Sorcha Hayward directly on +353 1 6321866 for a confidential discussion.
