GSK Hiring Regulatory Specialist (CMC)

GSK Hiring Regulatory Specialist (CMC Renewals) – 1 to 2 Years Experience | Bengaluru Pharma Jobs

GSK is hiring Regulatory Specialist professionals for its CMC (Chemistry, Manufacturing and Controls) Renewals team with multiple vacancies across Bengaluru and global locations. This is a full-time opportunity ideal for candidates with 1 to 2 years of experience in regulatory affairs, pharmaceutical documentation, and drug development processes. The role focuses on global regulatory submissions, CMC documentation, and lifecycle management of pharma and vaccine products.

Company Overview

GSK (GlaxoSmithKline) is a leading global biopharmaceutical company focused on improving global health through innovative medicines, vaccines, and scientific advancements. With a strong presence across multiple therapeutic areas including oncology, infectious diseases, immunology, and respiratory care, GSK plays a major role in advancing healthcare worldwide.

The company combines science, technology, and talent to deliver high-quality pharmaceutical products while maintaining strict regulatory compliance and global standards. GSK is widely recognized for its strong regulatory framework, digital transformation initiatives, and commitment to patient safety.

Job Role & Responsibilities

As a Regulatory Specialist in the CMC Renewals team, you will be responsible for managing regulatory submissions related to manufacturing, quality control, and product lifecycle maintenance. This role is critical in ensuring continued approval and compliance of pharmaceutical and vaccine products in global markets.

Core Responsibilities

• Manage multiple CMC renewal submissions for pharmaceutical and vaccine products
• Prepare, review, and compile regulatory dossiers in line with ICH CTD requirements
• Respond to regulatory authority queries and ensure timely submission approvals
• Assess data and ensure compliance with internal and global regulatory standards

Regulatory Strategy & Compliance

• Define regulatory strategies for product renewals and lifecycle management
• Identify risks in submission data and escalate critical issues
• Monitor global regulatory changes and implement necessary updates
• Ensure compliance with international regulatory guidelines and policies

Cross-Functional Collaboration

• Work closely with Global Manufacturing & Supply teams and local operating units
• Coordinate with stakeholders to deliver high-quality regulatory submissions on time
• Support digital transformation initiatives and regulatory systems improvement

Process Improvement & Intelligence

• Identify opportunities to improve regulatory processes and systems
• Monitor regulatory intelligence and proactively adapt to changing requirements
• Maintain accuracy, consistency, and completeness in regulatory documentation

Eligibility / Qualifications

Educational Qualification

Candidates must have a degree in Life Sciences, Chemistry, or related healthcare disciplines.

Required courses include:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc (Chemistry, Biotechnology, Microbiology, Biochemistry, Life Sciences), Biomedical Sciences, Clinical Research

Experience

• 1 to 2 years of experience in regulatory affairs or pharmaceutical industry
• Familiarity with CMC regulatory procedures and ICH CTD documentation

Skills Required

• Strong understanding of pharmaceutical regulatory processes and drug development lifecycle
• Excellent written and verbal communication skills
• Ability to manage multiple assignments and meet deadlines
• Strong analytical thinking and problem-solving skills
• Attention to detail with focus on data accuracy and compliance

Preferred Skills

• Knowledge of Veeva Vault or regulatory information management systems
• Experience in global regulatory submissions and documentation
• Ability to work in cross-functional and global teams

Location & Salary

• Job Location: Bengaluru, India (Global locations also available)
• Work Mode: Hybrid (flexible working options)
• Employment Type: Full-time
• Salary: Competitive salary with annual bonus, healthcare benefits, and performance incentives

Application Process

Interested candidates can apply directly through the official GSK careers portal:

Apply Here: https://jobs.gsk.com/en-gb/jobs/437431

Why This Role Matters in Healthcare

Regulatory Specialists in CMC play a vital role in maintaining the quality, safety, and efficacy of pharmaceutical products. By ensuring compliance in manufacturing and regulatory submissions, this role helps sustain the availability of life-saving medicines and vaccines across global markets.

Frequently Asked Questions (FAQs)

1. What experience is required for this role?

Candidates need 1 to 2 years of experience in regulatory affairs or pharma industry.

2. What qualifications are required?

A degree in Life Sciences, Pharmacy, Chemistry, or related fields is required.

3. What does CMC mean in regulatory affairs?

CMC stands for Chemistry, Manufacturing, and Controls, which focuses on product quality, manufacturing processes, and regulatory compliance.

4. Is this a good pharma career option?

Yes. Regulatory affairs is a high-demand field with strong career growth in pharma and biotech industries.

5. What skills are important for selection?

Regulatory knowledge, attention to detail, communication skills, and ability to manage complex documentation.

Summary Table

Category	Details
Company	GSK
Vacancies	Regulatory Specialist (CMC Renewals)
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc (Chemistry, Biotechnology, Microbiology, Biochemistry, Life Sciences), Biomedical Sciences, Clinical Research
Experience	1–2 Years Regulatory Affairs Experience

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