Manager - Regulatory Affairs

Business Introduction

GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.

Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.

Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.

Position Summary

To support business objectives in efficient ways and in compliance with local legislation. Support Senior Manager to achieve India targets for submissions, approvals and LCM activities for the assigned products and also play a critical role in developing and implementing plan and working procedure of the department.

Responsibilities

• Project lead for assigned products for end to end management of regulatory submissions to CDSCO/DCGI for pharmaceutical, biopharmaceutical, and vaccine products including New Drug Applications, Line Extensions and Additional Indications, clinical trial applications, site registrations, regulatory content owner for packaging artwork creation/approval and life cycle management for marketed products.
• Ensure compliance with applicable Indian regulations, including the NDCT Rule 2019, Drugs & Cosmetics Act 1940 and Rules 1945, CDSCO requirements, and relevant regulatory guidelines.
• Liaise with Global Regulatory Affairs, Quality, Medical, Clinical, Pharmacovigilance, Manufacturing, and Supply Chain teams to obtain required documentation and ensure successful submissions.
• Maintain and manage regulatory information, submissions, and lifecycle activities through regulatory databases and KPIs within Veeva Vault and associated regulatory tracking systems.
• Support implementation and maintenance of Quality Management System (QMS) requirements for Regulatory Affairs activities.
• Evaluate regulatory intelligence for potential business risks, compliance impacts, and opportunities, and recommend appropriate actions.
• Ensure adherence to company SOPs and processes, regulatory procedures, and documentation standards.
  
  

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Educational Background
  
  

Minimum Level of Education: Bachelor's degree

Area of Specialisation: Life Sciences/Pharmacy

• Job-Related Experience
  
  

Minimum Level of Job-Related Experience required:

8-10 years of experience in Regulatory Affairs within Pharmaceuticals, Vaccines, Biologics, Biosimilars, Specialty Care, Oncology, Rare Diseases, or Gene Therapy.

Must have experience in:

• CDSCO & SUGAM submissions
• Product registrations and renewals
• Clinical trial approvals
• Licensing & import registrations
• Regulatory compliance
• Labeling and artwork review
• Cross-functional stakeholder management
  
  

How To Apply

If this role excites you, we encourage you to apply. Tell us about your relevant experience and what you would bring to the role. We welcome candidates from all backgrounds and encourage people who care about improving health to apply.

Skills

Agile Planning, Business Acumen, Change Management, Digital Fluency, Learning Agility, Problem Solving, Regulatory Strategies

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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