Regulatory Affairs Specialist - Belfast

About the Role

Our client is recruiting for a skilled Regulatory Affairs Specialist to enhance their team in Belfast, Northern Ireland . This role is pivotal in ensuring that pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance. This hybrid position offers a dynamic work environment combining office-based collaboration with the flexibility of remote working, supporting the company's mission in the Northern Ireland region.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., MAAs , variations, renewals) to health authorities.
• Ensure compliance with current regulatory requirements and guidelines for pharmaceutical products.
• Provide strategic regulatory advice to product development, manufacturing, and marketing teams.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.
• Liaise with regulatory agencies during the submission review process and respond to queries.
• Monitor changes in the regulatory landscape and assess their impact on the company's portfolio.

Requirements

• Degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Demonstrable experience in pharmaceutical regulatory affairs .
• Strong understanding of global regulatory submission processes and guidelines (e.g., ICH, FDA, EMA).
• Experience with dossier preparation and lifecycle management.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to work independently and as part of a collaborative team.

Benefits

• Competitive salary and a comprehensive benefits package.
• Health and wellness programs to support employee well-being.
• Pension scheme with generous employer contributions.
• Continuous learning and professional development opportunities.
• A flexible hybrid work model enhancing work-life integration in Belfast .