Regulatory Affairs Specialist

About the Role

Our client is seeking a diligent Regulatory Affairs Specialist to join their team in Belfast . This hybrid role is crucial for ensuring that all pharmaceutical products meet the complex and evolving regulatory requirements across various global markets. You will be responsible for preparing and submitting regulatory documentation, maintaining product registrations, and staying informed about changes in legislation. This position offers a balanced approach to work, combining remote flexibility with essential collaborative time on-site, supporting the successful launch and lifecycle management of vital pharmaceutical products.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registration and approval in target markets.
• Maintain existing product registrations and ensure ongoing compliance with relevant regulations.
• Monitor and interpret regulatory guidelines and advise on their impact on company operations.
• Act as a key liaison with regulatory agencies and health authorities.
• Review and approve promotional materials and product labeling for regulatory compliance.
• Support regulatory strategy development for new product launches and lifecycle management.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Proven experience in regulatory affairs within the pharmaceutical industry.
• Thorough understanding of international regulatory submission requirements and guidelines (e.g., FDA, EMA).
• Excellent attention to detail and strong organizational skills.
• Proficiency in regulatory information management systems and databases.
• Effective communication and negotiation skills, both written and verbal.

Benefits

• Competitive salary commensurate with experience.
• Hybrid work model allowing for flexible work arrangements.
• Private healthcare coverage and wellness programs.
• Company-sponsored training and professional development.
• Pension scheme and life insurance.