Regulatory Associate Manager I – Product Variations
📍 Location: Bengaluru, India
🏢 Category: Regulatory
🆔 Job ID: 428942
📅 Posted Date: October 14, 2025
Business Introduction
At GSK, we aim to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining immune system insights with cutting-edge technology to transform lives.
We foster a culture that is:
Ambitious for patients
Accountable for impact
Committed to doing the right thing
GSK unites science, technology, and talent to get ahead of disease together.
Find out more: Our approach to R&D
Basic Qualifications & Responsibilities
Education: Bachelor’s degree in Chemistry, Pharmacy, or related scientific/technical field.
Experience: Minimum 5 years in CMC (Chemistry, Manufacturing, and Controls).
Core Responsibilities:
Independently execute agreed dossier strategy.
Manage multiple BioPharm project assignments simultaneously, including complex projects.
Complete data assessments ensuring dossiers are fit for purpose.
Identify risks in submission data and escalate business-impacting issues.
Act as reviewer/approver for peer-prepared dossiers; identify regulatory process improvement opportunities.
Understand global regulations, guidelines, and procedures for pharmaceutical registration and manufacturing.
Serve as subject matter expert and mentor/trainer for new staff.
Build internal and external organizational networks (GSC, LOC, PO, stakeholders) and share knowledge/experience.
Communicate across GSK regarding project and policy issues to ensure optimal positioning.
Preferred Qualifications & Skills
Broad understanding of the pharmaceutical industry, drug development, and R&D processes.
Global regulatory submission experience and knowledge of regulatory agency guidelines.
Excellent organizational skills, attention to detail, and ability to deliver high-quality output under regulatory deadlines.
Strong written and verbal communication skills; ability to present information clearly and concisely.
Ability to interpret and advise on global guidelines and requirements.
Proven ability to build effective working relationships and thrive in a matrix organization.
Flexible mindset to manage shifting priorities and timelines.
Why GSK?
GSK unites science, technology, and talent to advance disease prevention and treatment.
Focus on positively impacting 2.5 billion people by decade-end.
Therapeutic areas: respiratory, immunology & inflammation, oncology, HIV, infectious diseases.
Culture: ambitious for patients, accountable for impact, doing the right thing.
Inclusion & Accessibility
GSK encourages candidates to request accommodations during the recruitment process.
Contact: IN.recruitment-adjustments@gsk.com
Employment Agency & Legal Notices
GSK does not accept unsolicited agency referrals without prior written authorization.
Beware of fraudulent job postings or emails requesting payment; GSK does not charge fees for recruitment.
Verify suspicious communications via askus@gsk.com.
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