Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is actively recruiting a knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their growing team in Reading . This role plays a vital part in navigating the complex regulatory landscape, ensuring that products meet all necessary legal and scientific requirements for approval and marketing worldwide. You will be responsible for preparing, submitting, and managing regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory guidelines. This is an excellent opportunity for a detail-oriented professional to influence product lifecycle management and contribute to global health initiatives.

Key Responsibilities

• Prepare and compile high-quality regulatory submission documents (e.g., CTD, IND, NDA) for global health authorities.
• Manage regulatory processes, including initial submissions, amendments, and annual reports.
• Liaise effectively with health authorities to respond to queries and facilitate product approvals.
• Monitor and interpret changes in global pharmaceutical regulations and guidelines.
• Collaborate with internal departments (R&D, Quality, Manufacturing) to ensure regulatory compliance.
• Provide regulatory guidance and support throughout the product development lifecycle.

Requirements

• Bachelor's or Master's degree in a life science, chemistry, or related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission requirements in key markets (e.g., FDA, EMA).
• Experience with electronic submission platforms and document management systems.
• Strong understanding of drug development processes and GMP/ICH guidelines.
• Excellent written and verbal communication skills, with meticulous attention to detail.

Benefits

• Competitive salary and performance-related bonus.
• Hybrid working model offering a balance of office and remote work.
• Comprehensive private medical insurance and employee assistance program.
• Company pension scheme and generous holiday entitlement.
• Continuous professional development and training opportunities.