Roles & Responsibilities:
• Develop and execute regulatory dossier strategies to meet business and regulatory objectives.
• Manage multiple CMC projects and regulatory submissions simultaneously, ensuring timelines and quality standards are met.
• Conduct data assessments to ensure dossiers are complete, accurate, and fit-for-purpose.
• Identify, document, and mitigate risks related to submission data and information packages.
• Escalate critical issues to line management and support resolution.
• Review peers’ dossiers, recommend improvements, and contribute to regulatory process enhancements.
• Act as subject-matter expert on applicable regulations, guidelines, and procedures for product registration and manufacturing.
• Provide consultation, training, and mentoring to colleagues.
• Build and maintain relationships with internal stakeholders and external authorities to support project and policy objectives.
Qualification:
• Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related technical discipline.
Experience:
• Minimum 5 years of regulatory affairs experience with a focus on CMC for small molecule products.
• Practical experience preparing and managing CTD Module 2 and 3 documentation or equivalent quality dossiers.
Skills:
• Strong project management skills and ability to handle multiple submissions.
• Excellent written and verbal communication skills in English.
• Ability to draft, review, and present regulatory content clearly.
• Knowledge of comparability assessments, change control, stability data interpretation is a plus.
• Experience mentoring colleagues and supporting health authority interactions.
About the Organisation:
GSK is a global biopharmaceutical company uniting science, technology, and talent to improve the health of 2.5 billion people by the end of the decade. With a focus on vaccines and specialty medicines across respiratory, oncology, HIV, and infectious diseases, GSK delivers innovative therapies while fostering a culture ambitious for patients, accountable for impact, and committed to inclusivity and employee development.
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