Regulatory Specialist

Walker Cole International is supporting a pharmaceutical organisation in Dublin in the appointment of a Regulatory Affairs Specialist on a 6-month contract. This role will provide regulatory support to ensure products remain compliant with EU and Irish regulatory requirements throughout their lifecycle.

The position will play a key role in maintaining regulatory compliance, supporting submissions and variations, and collaborating with cross-functional teams to ensure timely regulatory execution.

Key Responsibilities

• Support regulatory activities across marketed pharmaceutical products
• Prepare, compile and submit regulatory dossiers, variations, renewals and notifications
• Ensure compliance with EU, HPRA and other applicable regulatory requirements
• Maintain regulatory documentation and product lifecycle records
• Review and support product labelling, artwork and packaging updates
• Monitor regulatory changes and assess potential business impact
• Support responses to regulatory authority queries and information requests
• Collaborate with Quality, Supply Chain, Medical Affairs and Commercial teams on regulatory matters
• Support product launches, transfers and change management activities
• Contribute to continuous improvement of regulatory processes and systems

Required Experience and Skills

• Proven experience in Regulatory Affairs within the pharmaceutical industry
• Strong knowledge of EU pharmaceutical regulations and lifecycle management
• Experience preparing and managing variations, renewals and regulatory submissions
• Familiarity with HPRA and other European regulatory agencies
• Strong document management and attention to detail
• Excellent stakeholder engagement and communication skills
• Ability to manage multiple priorities in a fast-paced environment
• Eligible to work in Ireland

Working Pattern

Hybrid (Dublin)

Contract Length

6 months

Rate

Competitive daily rate, dependent on experience

Location

Dublin, Ireland

Keywords

Regulatory Affairs | Regulatory Specialist | EU Regulations | HPRA | Variations | Renewals | Pharmaceutical | Lifecycle Management | Contract | Dublin