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.

The Role

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.

The Person

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.