Senior Regulatory Specialist

GSK India

3 - 10 years

10 - 11 Lacs

bengaluru

Posted:1 day ago| Platform:

Apply

Skills Required

procurement supply chain change management manager quality assurance pharma analytical cms healthcare monitoring technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).
Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.
Preparing and coordinating the review and approval of submission-ready documents.
Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.
Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.
Building and maintaining strong relationships with internal and external stakeholders.
Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.
Identifying improvement opportunities for CMC regulatory processes, policies, and systems.

Basic qualifications:

Bachelor s or Master s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
Thorough understanding of change management processes and regulatory requirements.
Attention to detail with an emphasis on accuracy and completeness.
Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
Flexible and analytical thinking to independently provide solutions to issues.
Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
Excellent written and verbal communication skills in English.

What we offer:

Career with purpose - whatever it is you re doing, you ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).
Hybrid working model ( 2/3 days per week in the office).
Career at one of the leading global healthcare companies.
Supportive & friendly working environment.
Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.

More Jobs at GSK India

Safety Evaluation Scientist-Literature

Bengaluru

3 - 6 yrs

INR 5 - 8 Lacs

Information Security training and Awareness Senior Analyst

Bengaluru

5 - 10 yrs

INR 7 - 12 Lacs

Senior Lead Cyber Security Risk Analyst

Bengaluru

5 - 10 yrs

INR 7 - 12 Lacs

Information Security Training & Awareness Senior Analyst

Bengaluru

5 - 10 yrs

INR 7 - 12 Lacs

Team Lead Document Anonymization

Bengaluru

10 - 15 yrs

INR 35 - 45 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.