GSK Careers 2025 | MSc Chemistry Graduates Apply Now for Regulatory Affairs Specialist
GSK, a leading global biopharma company, is hiring a Senior Regulatory Specialist across multiple locations, including Warsaw, Bengaluru, Cairo, and Poznan. This role offers an exciting opportunity to manage CMC variation projects and Global Supply Chain change programs, ensuring regulatory compliance for pharmaceutical products worldwide. Ideal candidates will have experience in regulatory affairs, post-approval CMC procedures, and ICH CTD documentation.
- Job ID: 423555
- Location: Bengaluru
GSK Careers 2025 – Senior Regulatory Specialist
GSK invites applications for the position of Senior Regulatory Specialist at global locations: Warsaw, Bengaluru, Cairo, and Poznan. This role is part of the Delivery Team within SMMP. It plays a key role in driving Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products.
Key Responsibilities
- Manage multiple CMC projects, source transfers, and Health Authority Questions (HAQs) for APIs, intermediates, and drug products using CTD Module 3 – Quality dossiers.
- Execute dossier strategies and assess data for regulatory compliance across local and international markets.
- Prepare and coordinate submission-ready documents for approval.
- Collaborate with cross-functional teams: Global Regulatory, Supply Chain, Quality Assurance, CMO, and Contract Manufacturing Organizations.
- Mentor and train new team members to ensure high-quality delivery.
- Monitor regulatory intelligence and implement changes in requirements.
- Identify process improvements for CMC regulatory policies, processes, and systems.
Basic Qualifications
- Bachelor’s or Master’s in Biotechnology, Chemical Technology, Pharmacy, Chemistry, or related scientific/technical fields.
- Relevant experience in regulatory affairs in the pharmaceutical industry, including post-approval CMC procedures and ICH CTD documentation (Modules 2 & 3).
- Strong understanding of drug development, regulatory processes, and change management.
- Excellent interpersonal, communication, and analytical skills, with the ability to manage multiple tasks.
What GSK Offers?
- Career with purpose – contribute to improving human health globally.
- Non-wage benefits: medical care, life insurance, pension, recreation allowance, and preventive healthcare.
- Hybrid working model (2–3 days per week in the office).
- Global career opportunities in a supportive and inclusive work culture.
- Corporate culture focused on ambition for patients, accountability, and integrity.
GSK is an Equal Opportunity Employer, committed to diversity and inclusion, where employees are inspired and encouraged to thrive.
For more details about the Regulatory Affairs Specialist, including global regulatory roles and responsibilities, visit GSK Careers online.
