Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a knowledgeable and diligent Regulatory Affairs Specialist to support their pharmaceutical operations in Leeds . This role is critical for ensuring that all products meet stringent national and international regulatory standards, facilitating market access and compliance. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This position offers a chance to work on diverse projects within a respected organisation, contributing to the successful launch and lifecycle management of pharmaceutical products.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities (e.g., MHRA, EMA).
• Interpret and apply regulatory guidelines and legislation to product development, manufacturing, and marketing activities.
• Liaise effectively with internal departments (R&D, Quality, Marketing) and external regulatory agencies to ensure compliance.
• Maintain regulatory databases and filing systems, ensuring all documentation is up-to-date and accessible.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess their impact.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.

Requirements

• Degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs .
• In-depth knowledge of regulatory submission processes and guidelines in key markets (e.g., UK, EU).
• Experience with dossier preparation (e.g., CTD format) and regulatory submission software.
• Strong analytical, problem-solving, and communication skills.

Benefits

• Competitive annual salary and bonus structure.
• Hybrid working model combining office-based collaboration and remote flexibility.
• Comprehensive benefits package including health insurance and pension contribution.
• Opportunities for career growth and specialized training in regulatory science.
• A dynamic and supportive work environment within a leading pharmaceutical company.