Regulatory Affairs Associate

About the Role

Our client is looking for a proactive Regulatory Affairs Associate to support their product registration activities. This hybrid role in our Belfast office is key to ensuring our pharmaceutical products meet all necessary regulatory requirements for market approval and compliance. You will assist in preparing submission dossiers, liaising with health authorities, and maintaining regulatory compliance documentation. This is a vital role for an individual detail-oriented and keen to navigate the complex regulatory landscape of the pharmaceutical sector.

Key Responsibilities

• Assist in the preparation and submission of regulatory dossiers to health authorities in various regions.
• Maintain regulatory documentation, including product registration files and compliance records.
• Monitor changes in regulatory legislation and guidance documents relevant to the pharmaceutical industry.
• Liaise with internal departments (e.g., R&D, Marketing, Quality Assurance) to gather information for submissions.
• Respond to queries from regulatory agencies and provide necessary follow-up information.
• Support post-approval regulatory activities, such as variations and renewals.

Requirements

• Bachelor's degree in a relevant scientific or technical field.
• 1-2 years of experience in regulatory affairs within the pharmaceutical industry.
• Familiarity with regulatory submission processes and guidelines (e.g., CTD format).
• Strong organizational skills and meticulous attention to detail.
• Good written and verbal communication skills.
• Ability to work effectively both independently and as part of a team.

Benefits

• Competitive salary package.
• Flexible hybrid working arrangement.
• Comprehensive healthcare benefits.
• Contribution to a company pension plan.
• Access to training programs and professional development.