In today’s rapidly evolving pharmaceutical landscape, the role of Regulatory Affairs (RA) professionals has never been more critical. Merck, a global leader in science and technology, is seeking talented individuals who can navigate complex global regulations while ensuring that healthcare innovations reach patients safely and efficiently.

Specialist – Regulatory Affairs Manager

Job ID: 286151

Location: Bangalore, Karnataka, India

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An exciting opportunity is now open for a Specialist – Regulatory Affairs at Merck’s Bangalore – Electronic City location.

The Role: Bridging Science and Regulation

As a Specialist in Regulatory Affairs at Merck, you will play a key role in preparing regulatory dossiers and executing compliance strategies that secure product licenses across diverse global markets. Your work will be pivotal in balancing the company’s internal goals with the rigorous standards of health authorities worldwide.

Working in a matrix organization, you will collaborate across disciplines, engaging with stakeholders both inside and outside the Global Regulatory Affairs function. With guidance from experienced license management professionals, you will take on complex challenges, helping to shape regulatory strategies and ensure regulatory submissions are executed with excellence.

Ideal Candidate Profile

This role seeks individuals who combine scientific expertise with a deep understanding of global regulatory frameworks.

Experience Requirements:

• At least 5 years of overall experience in the pharmaceutical industry, regulatory bodies, or R&D environments.

• Minimum 1 year of hands-on regulatory affairs experience, preferably with exposure to international markets.

Educational Background:

• A Life Sciences degree is essential; a Master’s (MSc) is preferred.

Key Skills:

• Expertise in preparing full international submissions and managing large variations.

• Knowledge of life-cycle management activities in multiple regions (Europe, USA, etc.).

• Strong familiarity with regulatory dossiers, post-approval changes, and essential supporting documents like CPPs, GMP Certificates, and Manufacturing Licenses.

• Ability to interpret complex regulatory guidelines and produce submission-ready deliverables.

• Proficiency in regulatory tools such as RIM systems, Vault, and EDMS.

• Excellent project management, communication skills, and English proficiency.

Life at Merck: A Culture of Diversity, Innovation, and Growth

At Merck, diversity, equity, and inclusion are deeply rooted values. The company recognizes that varied perspectives drive innovation and creativity. Merck stands firmly against discrimination in all forms, ensuring equal opportunities based on merit and passion for excellence.

With access to continuous development opportunities, mentorship from industry leaders, and a culture that embraces curiosity and collaboration, employees at Merck are empowered to chart their own growth journeys.

Why You Should Apply

If you are a regulatory affairs professional eager to make a tangible impact in a leading global organization — one that values diversity, innovation, and human progress — this role at Merck could be your next great career move.

Apply today and join Merck’s dynamic team working to advance science and technology for millions around the world!

APPLY HERE