Regulatory Affairs Specialist

• Develop and implement regulatory strategies for medicinal products throughout their lifecycle
• Independently prepare and manage regulatory submissions, including new marketing authorization applications, variations, renewals, and responses to regulatory authority questions
• Compile, review, and coordinate regulatory dossiers in accordance with UK and EU regulatory requirements
• Write and review technical regulatory documentation, including Module 3 sections, Quality Overall Summaries (QOS), packaging texts, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling documents
• Provide regulatory guidance and technical expertise to clients and internal project teams
• Serve as the primary regulatory contact for clients and liaise directly with regulatory authorities
• Monitor and assess changes in regulations and advise clients on potential impacts to their products and activities
• Coordinate and review technical documentation to ensure compliance with regulatory standards
• Prepare and review user testing readability reports
• Document, track, and maintain records of regulatory submissions and approvals
• Support project teams by ensuring regulatory requirements are incorporated into project planning and execution
• Review work completed by Regulatory Affairs Associates and provide mentoring, coaching, and technical guidance
• Contribute to systems management and administrative activities related to regulatory operations
• Deliver high-quality regulatory consultancy services while maintaining strong client relationships

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline
• Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry
• Strong experience with UK regulatory requirements and procedures
• Proven experience managing regulatory submissions and lifecycle maintenance activities for medicinal products
• Experience serving as the primary regulatory contact for clients and health authorities
• In-depth knowledge of UK and EU regulatory frameworks and regulatory authorities
• Strong expertise in regulatory dossier preparation and submission management
• Experience writing and reviewing regulatory and technical documents
• Sound understanding of medicinal product lifecycle management
• Excellent analytical, organizational, and problem-solving skills
• Strong verbal and written communication skills
• Ability to manage multiple projects and deadlines in a fast-paced environment
• Fluent English (written and spoken)
• Client-focused approach
• Strong attention to detail
• Excellent stakeholder management skills
• Ability to work independently and collaboratively
• Proactive, organized, and solution-oriented mindset
• Commitment to quality and continuous improvement

• Opportunity to make a meaningful impact on global healthcare
• Career growth opportunities
• Work with an innovative, forward-thinking global team
• Purpose-driven work
• Remote work arrangement