Regulatory Associate Manager III – CMC
Location: Bengaluru, Karnataka, India
Function: Regulatory Affairs
Employment Type: Full-Time
Job ID: 434198
Experience Required: Minimum 5+ years in Regulatory Affairs (CMC – Small Molecules)
Work Location: Bengaluru Luxor North Tower
About GSK
GSK is a global biopharmaceutical company driven by the purpose of uniting science, technology, and talent to get ahead of disease together. With ambitious goals to positively impact the health of 2.5 billion people by the end of the decade, GSK focuses on developing innovative vaccines and medicines across key therapeutic areas including respiratory, immunology, oncology, HIV, and infectious diseases. GSK fosters a culture that is ambitious for patients, accountable for impact, and grounded in integrity.
Job Overview
GSK is seeking an experienced Regulatory Associate Manager III to support global regulatory activities with a strong focus on CMC (Chemistry, Manufacturing, and Controls) for small molecule products. This role plays a critical part in ensuring timely, high-quality regulatory submissions across multiple projects and dosage forms.
The position acts as the CMC regulatory representative on global regulatory networks and matrix teams, providing expert guidance to Global Supply Chain, Commercial, Quality, Third-Party Manufacturing, and Medical teams. The role also includes mentoring junior regulatory professionals and serving as a subject matter expert in assigned regulatory areas.
Key Responsibilities
Independently develop and execute global regulatory dossier strategies aligned with business and submission objectives
Manage multiple regulatory projects concurrently, ensuring adherence to timelines, quality standards, and regulatory expectations
Lead comprehensive data assessments to ensure CMC dossiers are complete, accurate, and submission-ready
Identify, document, and mitigate regulatory and CMC-related risks associated with submission content
Escalate critical regulatory issues with potential business impact and support timely resolution
Review peer regulatory dossiers and contribute to continuous improvement of regulatory processes, systems, and policies
Serve as a subject matter expert on global regulatory requirements, guidelines, and CMC expectations for product registration and manufacturing
Provide regulatory consultation, training, and mentoring to team members and cross-functional stakeholders
Build and maintain strong internal and external stakeholder relationships to support regulatory and compliance objectives
Required Qualifications & Experience
Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related technical discipline
Minimum 5 years of hands-on regulatory affairs experience, with a strong focus on CMC for small molecule products
Demonstrated experience preparing, reviewing, and managing CTD Modules 2 and 3 or equivalent quality dossiers
Strong project management skills with the ability to manage multiple regulatory submissions simultaneously
Proficiency in written and spoken English, with the ability to draft, review, and present regulatory documentation clearly and effectively
Preferred Qualifications
Proven experience responding to health authority queries and supporting inspection readiness activities
Experience working in a matrix and cross-functional environment, including supply chain, manufacturing, and commercial teams
Familiarity with comparability assessments, change control processes, and stability data interpretation
Prior experience mentoring or training regulatory colleagues
Why Join GSK
Be part of a global organization committed to advancing science and improving patient lives at scale
Work on high-impact regulatory projects supporting innovative medicines and vaccines
Collaborate with diverse, global teams in a dynamic and inclusive environment
Grow professionally in a company that values learning, accountability, and ethical leadership
Inclusion & Equal Opportunity
GSK is an equal opportunity employer and is committed to fostering an inclusive workplace. Reasonable adjustments are available throughout the recruitment process upon request.
Recruitment Fraud Advisory
GSK does not charge any fees at any stage of the recruitment process. Candidates are advised to verify the authenticity of all job-related communications and to engage only with official GSK email domains.
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