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 pharmaceutical portfolio.
Duties and responsibilities of the Reg Affairs Manager will include but are not limited to:
- Submission of:
- labelling changes based on the CCDS according to pharma SOPs.
- quality related changes according to the agreed timeliness.
- DSURs according to SOP and the local legislation.
- applications for new Marketing Authorisation, line extensions and new indications.
- Regular monitoring of the submission status with the authorities.
- Timely update of internal and external databases and document management systems
- Providing relevant information on RA milestones to GRA and other functions on the local level (Medical, PV, Product Supply, Business, Communication, Market Access, etc.).
- Archiving of all documents and correspondence submitted to and received from the Authority according to the Global SOP and locally agreed processes.
- Contribute to ensure that all local procedures comply with global directives and procedures.
- Writes, reviews and approves documents applicable to this department, as described in the procedure on SOP management.
- Give needed RA support to Quality Manager to perform the investigations and CAPA.
- Ensures that the correct texts are used for the packaging materials as described in the procedures on repackaging and extra labelling activities
- Provides guidance on regulatory obligations and company policies for the management of self-inspections
- Has overall responsibility for the publication of SmPC and PIL for allocated products on the regulatory product information databases.
You will have skills and experience in the following:
- BSc, MSc or PhD in life science or pharmacy.
- Minimum 2 years' experience.
- Experience in a national and/or regional registration procedure.
- Fluency in English.
- Requires adequate negotiating, interpersonal and influencing skills.
- Commercial awareness, good project management skills and an ability to adapt to changing priorities.
- 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.