Our client, a Top 10 global healthcare and consumer goods organisation based in South Dublin, are seeking a Regulatory Affairs Manager to manage the domestic regulatory aspect of their Consumer Health portfolio.
Duties and responsibilities of the Reg Affairs Manager will include but are not limited to:
- Ensure regulatory compliance and delivery of local milestones for the Consumer Health (CH) range of products in the portfolio.
- Maintain PA licences for CH products registered with the HPRA via the National, MRP and Centralised routes e.g. submission of variations, renewals, responses to queries, PSURS, line extensions) etc.
- Ensure timely submission of labelling update and implementation to pack (including artwork review and approval).
- Adhere to local & Global SOP's, OI's and contribute to creation, review and update of same as required.
- Support the CH business as required with Patient enquiries, switch applications, product launch activities etc.
- Timely update of internal and external systems to ensure regulatory compliance as per the required process e.g. submissions database.
- Review & generation of registration documentation to ensure good quality and a right first time approach
- Ensure timely implementation of CMC updates
- Archive all Regulatory related documentation
- Develop and maintain good working relationship with Supervisor, other team members and cross functional colleagues
You will have skills and experience in the following:
- Sc, MSc or PhD in life science or pharmacy.
- Experience in national and/or regional registration procedure.
- Minimum 2 years experience.
- Fluency in English.
- Must be able to work as a team, have excellent organization skills and attention to detail.
- Requires adequate negotiating, interpersonal and influencing skills.
- Commercial awareness particularly in the Consumer Health business is an advantage with the ability to adapt to a changing environment.
- Knowledge of national and regional pharmaceutical regulatory requirements.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.