Regulatory Associate Manager – Product Variations
Job Details
Company: GSK (GlaxoSmithKline)
Role: Regulatory Associate Manager – Product Variations-1
Function: Regulatory
Job ID: 440838
Work Arrangement: On-site (India – Bengaluru)
Locations: Bengaluru (India), Cairo (Egypt), Poznań (Poland), Warsaw (Poland)
Posted Date: 13 May 2026
Position Summary
This role is responsible for managing regulatory activities related to product variations across multiple countries and dosage forms. The position requires working in a global matrix environment and ensuring timely delivery of regulatory submissions for vaccines and pharmaceutical products.
The role supports CMC (Chemistry, Manufacturing and Controls) delivery teams and acts as a key contributor in global regulatory networks.
Key Responsibilities
Regulatory Submission & Dossier Management
Execute agreed regulatory dossier strategies independently.
Manage multiple Rx and/or Vaccine (Vx) projects simultaneously.
Ensure regulatory submissions are complete, accurate, and fit-for-purpose.
Review and validate submission data and documentation.
Risk & Issue Management
Identify risks in submission data and regulatory packages.
Escalate critical issues to management as required.
Ensure timely resolution of regulatory risks affecting business outcomes.
Cross-Functional Collaboration
Represent CMC Delivery in regulatory and matrix teams.
Collaborate with:
Pharma Supply Chain (PSC)
Commercial teams
Quality Assurance (QA)
Contract Manufacturing Organizations (CMOs)
Office of the Chief Medical Officer (OCMO)
Ensure alignment across global stakeholders for submission readiness.
Compliance & Regulatory Expertise
Ensure compliance with global regulatory guidelines and submission requirements.
Maintain understanding of:
Regulatory agency guidelines
Drug registration processes
Pharmaceutical manufacturing regulations
Support global regulatory filings and approvals.
Leadership & Knowledge Sharing
Act as mentor or trainer for new team members.
May serve as Subject Matter Expert (SME) in specific regulatory areas.
Support knowledge sharing across teams and departments.
Review & Process Improvement
Review regulatory dossiers prepared by peers (as approver/reviewer if assigned).
Identify opportunities for improving regulatory processes, systems, and policies.
Contribute to continuous improvement initiatives.
Communication & Stakeholder Management
Communicate effectively across global GSK teams.
Build strong working relationships in a matrix environment.
Ensure clarity on regulatory strategies, timelines, and submissions.
Required Qualifications
Education
Bachelor’s degree in:
Pharmacy
Chemistry
Life Sciences or related technical/scientific field
Experience
3–8 years of experience in pharmaceutical or regulatory environment.
Experience in:
Global or EMAP regulatory submissions
Drug development processes
Regulatory agency guidelines
Exposure to complex scientific or regulatory environments.
Skills Required
Strong understanding of global regulatory requirements
Excellent attention to detail
Strong organizational and time management skills
Ability to manage multiple priorities simultaneously
Strong written and verbal communication skills
Ability to interpret global regulatory guidelines
Stakeholder management in matrix environments
Flexibility to handle changing priorities and deadlines
Preferred Attributes
Experience in pharmaceutical R&D environment
Strong understanding of CMC regulatory processes
Ability to mentor junior team members
Experience working in global cross-functional teams
Work Environment
On-site role in India with collaboration across global teams.
Participation in cross-site virtual meetings and global projects.
About GSK
GSK is a global biopharma company focused on uniting science, technology, and talent to get ahead of disease together. The company works across key therapeutic areas including:
Oncology
HIV
Respiratory
Immunology & Inflammation
Infectious Diseases
Important Notes
GSK does not charge any fee for recruitment.
Only official emails ending in @gsk.com are valid.
Candidates should report suspicious recruitment activity to:
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