Manager - Regulatory Affairs

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:

A. Educational Background

Minimum Level of Education: Bachelor's degree

Area of Specialisation: Life Sciences/Pharmacy

B. 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 [email protected] to discuss your needs.

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