Global Regulatory Affairs Specialist

As a Global Regulatory Affairs Specialist at G&L Scientific, you will play a crucial role in providing subject matter expertise and supporting internal SMEs during a significant regulatory transformation initiative. Your primary focus will be on ensuring the continuity of day-to-day regulatory operations, with a specific emphasis on CMC, labeling, and lifecycle management activities. Key Responsibilities: - CMC Documentation Support: - Compile, review, and maintain Chemistry, Manufacturing, and Controls (CMC) documentation - Coordinate with Quality, Manufacturing, and regulatory teams to ensure accuracy and completeness - Labeling Activities: - Review and update product labeling in accordance with regulatory and internal requirements - Ensure alignment between approved labeling and market implementation - Regulatory Operations & Lifecycle Management: - Support preparation, review, and submission of regulatory filings - Ensure compliance with CHC regulatory standards, policies, and timelines - Contribute to lifecycle activities including variations, renewals, and maintenance submissions Required Skills & Experience: - Experienced in Regulatory Affairs, ideally with exposure to CMC, labeling, or lifecycle management - Detail-oriented, organized, and comfortable coordinating across multiple functions - Able to manage priorities in a fast-moving, global environment - Strong communicator with a compliance-focused mindset Joining G&L Scientific offers you the opportunity to work at the forefront of global drug development, embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants. If you are passionate about regulatory excellence and digital transformation in life sciences, we would love to hear from you. Apply by sending your CV to [email protected] At G&L Scientific, we recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.,