Biotechnology Jobs in Bangalore: GSK is Hiring a Regulatory Associate Manager | Apply Now
Are you a Biotech graduate looking for biotechnology jobs in Bangalore? GSK is hiring a Regulatory Associate Manager (CMC Variations, Small Molecules) in Bangalore, India, to lead global regulatory activities, ensuring compliance, quality, and innovation in pharmaceuticals. This full-time position offers an exciting opportunity to work on transformative projects that unite science, technology, and talent to get ahead of disease impacting the health of billions worldwide while advancing your GSK career.
Job Details:
- Job Title: Regulatory Associate Manager – CMC Variations, Small Molecules
- Location: Bangalore, India
- Function: Regulatory
- Work Type: Full-Time
- Job ID: 430069
About the Company
GlaxoSmithKline (GSK) is a leading global biopharmaceutical company with a purpose to unite science, technology, and talent to get ahead of disease together. With a vision to positively impact the health of 2.5 billion people by the end of the decade, GSK focuses on developing innovative vaccines and specialty medicines that prevent and treat diseases effectively.
Operating across more than 100 countries, GSK’s work spans therapeutic areas such as respiratory, immunology, oncology, HIV, and infectious diseases. The company’s research-driven culture fosters collaboration, diversity, and ethical innovation, ensuring long-term health
impact for patients and communities worldwide. GSK Careers offer professionals a purpose-driven path—empowering individuals to thrive in an inclusive, innovative, and patient-focused environment while contributing to global healthcare advancements.Education:
Bachelor’s or Master’s degree in Biotechnology, or related field.
Key Responsibilities:
- Manage regulatory activities for product variations, ensuring compliance and timely delivery.
- Collaborate with internal and external stakeholders to produce high-quality components for global dossiers.
- Assess data to ensure submissions are fit for purpose and identify risks in submission packages.
- Act as reviewer or approver for regulatory dossiers prepared by peers.
- Provide guidance on regulatory requirements, policies, and procedures.
- Build effective networks within GSK to share knowledge and promote best practices.
Basic Qualifications:
- Experience managing CMC variations, source transfers, and handling Health Authority Questions (HAQs) for finished products, intermediates, and APIs.
- Expertise in CTD Module 3 (Quality section of dossiers).
- Strong understanding of global regulatory requirements (EU, US, international).
- Ability to manage multiple projects, assess risks, and ensure submission quality.
- Collaboration with Product Owners, Project Managers, and global teams to deliver dossiers on time.
Preferred Qualifications:
- Relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Familiarity with post-approval CMC procedures and ICH CTD documentation.
- Strong analytical, communication, and interpersonal skills.
- Proven ability to handle multiple priorities and adapt to dynamic project needs.
- Excellent written and verbal English communication skills.
Joining GSK as a Regulatory Associate Manager offers a unique opportunity to contribute to life-changing innovations in global healthcare. In this biotechnology job role, you’ll lead impactful regulatory projects, collaborate with world-class experts, and ensure quality and compliance across markets. GSK’s commitment to uniting science, technology, and talent creates an inspiring environment where you can grow your career while helping millions live healthier lives.
