GSK Careers India: Regulatory Manager Position Open| Apply Now
Explore a high-impact opportunity with GSK careers as a Regulatory Associate Manager – CMC Variations, ideal for professionals seeking growth in Pharma jobs and M Pharma jobs. This role, based in Bengaluru, India and Poznan, Poland, offers the chance to lead global regulatory activities for small molecules while collaborating with cross-functional teams. If you’re looking to advance your career in regulatory affairs with a world-leading biopharma organization, this GSK regulatory position is a perfect next step.
Job Details:
- Job Position: Regulatory Associate Manager- CMC Variations, Small Molecules
- Location: Bengaluru, India; Poznan Grunwaldzka, Poland
- Department: Regulatory
- Job ID: 430069
About The Company:
GSK is a global biopharma company uniting science, technology, and talent to get ahead of disease together. With a mission to positively impact 2.5 billion lives by the end of the decade, GSK focuses on innovation in vaccines and specialty medicines across therapeutic areas including infectious diseases, oncology, respiratory, and HIV. The company fosters a culture centered on patient impact, accountability, and doing the right thing.
Job Description (M Pharma Jobs)
The Regulatory Associate Manager will lead regulatory activities for product variations, ensuring compliance, quality, and timely submission across multiple global projects. This role requires collaboration with supply chain, QA, commercial teams, and global regulatory groups to support major dossier submissions.
Key Responsibilities at GSK careers:
- Manage regulatory activities for product variations across global projects.
- Collaborate with internal and external stakeholders for regulatory dossier development.
- Assess data for submission readiness and identify regulatory risks.
- Review or approve regulatory documents prepared by peers.
- Provide guidance on regulatory requirements and expedite approval processes.
- Support product owners and global teams in planning and delivering regulatory strategies.
- Maintain strong networks across global regulatory and supply chain functions.
- Monitor regulatory intelligence and implement process improvements.
Basic Qualifications For GSK Careers
- Experience managing CMC variations, source transfers, and HAQs for finished products, intermediates, and APIs.
- Proficiency in CTD Module 3 and regulatory quality documentation.
- Strong project management experience with regulatory dossier strategies.
- Ability to collaborate cross-functionally with global and local teams.
- Ability to prepare and review submission-ready documents.
- Experience monitoring global regulatory requirements and changes.
Preferred Qualifications
- Bachelor’s/Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or related fields.
- Experience in regulatory affairs within the pharmaceutical industry.
- Familiarity with ICH CTD Modules 2 & 3 and post-approval CMC processes.
- Strong analytical, communication, and problem-solving skills.
- Ability to handle multiple tasks in a dynamic environment.
Why Choose This Company?
GSK offers an environment where employees thrive, innovate, and grow in a purpose-led organization. With a focus on preventing and treating diseases through science-led innovation, GSK is committed to inclusion, collaboration, and creating long-term impact.
