Regulatory Affairs Specialist

About the Role

Our client is seeking an experienced Regulatory Affairs Specialist to join their dedicated team in Belfast . You will play a vital role in ensuring that the company's pharmaceutical products comply with all relevant national and international regulations. This involves preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This hybrid role offers a balance of working from home and collaborating with colleagues at our Belfast office, contributing to bringing essential medicines to market safely and efficiently.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new product registrations and variations.
• Maintain compliance with current regulatory requirements and guidelines across key markets.
• Serve as the primary contact for regulatory agencies, responding to queries and requests.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment.
• Support the regulatory aspects of product lifecycle management and post-market surveillance.

Requirements

• Degree in a life science, pharmacy, or related discipline.
• Proven experience (3+ years) in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations (e.g., EMA, FDA).
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects and meet strict deadlines.

Benefits

• Attractive salary and performance bonus.
• Health insurance and company wellness programs.
• Pension contribution and life assurance.
• Opportunities for international travel and professional growth.
• A dynamic and supportive working environment in Belfast .