Director, Regulatory CMC

Director – Regulatory CMC Are you a CMC regulatory expert with experience across product development, submissions, and lifecycle management? This is an opportunity to lead on CMC regulatory strategy for a biopharma organisation advancing innovative therapies across multiple modalities. THE COMPANY This pioneering biopharmaceutical company is committed to transforming patient outcomes through cutting-edge science in ophthalmology, neuroscience, and rare diseases. Operating globally, the organisational culture prioritises collaboration, innovation, and continuous learning. As part of our team, you will be responsible for developing and implementing CMC regulatory strategies that ensure compliance with global regulations, while also driving business growth. KEY RESPONSIBILITIES Develop and implement CMC regulatory strategies to support product development, submissions, and lifecycle management Collaborate with cross-functional teams to ensure alignment on regulatory requirements and timelines Provide expert guidance on CMC regulatory matters to internal stakeholders and external partners Ensure compliance with global regulations, including ICH guidelines, FDA, EMA, and other relevant authorities Develop and maintain relationships with regulatory agencies, industry associations, and other stakeholders KEY QUALIFICATIONS AND SKILLS Bachelor's or Master's degree in a life science-related field (e.g., biology, chemistry, pharmacology) At least 8 years of experience in CMC regulatory affairs, preferably in the biopharmaceutical industry Strong understanding of global regulations, including ICH guidelines, FDA, EMA, and other relevant authorities Proven track record of developing and implementing effective CMC regulatory strategies Excellent communication, collaboration, and project management skills Ability to work independently and as part of a team Strong analytical and problem-solving skills Proficiency in MS Office applications (Word, Excel, PowerPoint) and ability to learn new software systems BENEFITS Competitive salary package Comprehensive benefits package, including health insurance, retirement plan, and paid time off Opportunities for professional growth and development within the company Collaborative and dynamic work environment with a diverse team of experts