This privately owned pharmaceutical organisation have an extensive portfolio of healthcare products and a robust drug development pipeline. They have a product presence in approximately 190 countries worldwide. A vacancy has opened up for a Senior Regulatory Affairs Officer to join the Corporate Regulator Group on a 12-month fixed-term contract.

The Role

Duties and responsibilities of the Senior Reg Affairs Officer will include:

• Maintenance of approved marketing authorisation (MA) dossiers through submission of variations, renewals, follow-up measures and PSURs
• Preparation of the above submissions in collaboration with other departments and partner companies
• Preparation of responses to regulatory authority queries
• Publishing of regulatory submissions using NextDocs and eCTD Manager software
• Review and approval of product artworks to ensure compliance with the relevant MA
• Maintenance of the company's manufacturing licence by submission of any necessary variations to the HPRA
• Regulatory compliance activities relevant to the company's manufacturing site, including review of change controls and GMP documentation (specifications, batch records etc.)

The Person

You will have skills and experience in the following:

• BSc in a life sciences discipline or similar
• A working knowledge of European pharmaceutical regulations, Directives and guidelines
• 3-4 year's work experience in pharmaceutical Regulatory Affairs
• Excellent attention to detail
• Strong computer and administrative skills
• Excellent verbal and written communication skills

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.