Regulatory Affairs Manager

Actively Reviewing the Applications

Lonza

India, Haryana Full-Time On-site

Posted 2 hours ago • Apply by May 24, 2026

Job Description

India, Haryana

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a Regulatory Affairs Manager within Lonza’s Capsules & Health Ingredients (CHI) business, you will play a critical role in ensuring regulatory compliance of our product portfolio across South Asia, including India, Pakistan, Bangladesh, Bhutan, Nepal, and Sri Lanka.

You will be the primary regulatory interface with Indian health and food authorities, supporting the CHPL manufacturing site and collaborating closely with site and global Quality, R&D, and Commercial teams. In this role, you will leverage regulatory expertise not only to ensure compliance, but also as a strategic enabler for business growth and customer success.

What You’ll Get

An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Opportunities to work with global regulatory networks and cross-functional teams.
Exposure to diverse regulatory frameworks across food, dietary supplements, feed, and pharmaceutical applications.

The full list of our global benefits can be found at:

https://www.lonza.com/careers/benefits

What You’ll Do

Lead regulatory surveillance activities for the South Asia region, proactively monitoring new regulations, standards, and regulatory trends to ensure continued compliance and identify business opportunities.
Translate regulatory requirements into clear action plans and ensure effective implementation across site and regional teams.
Maintain facility and product registrations, licenses, and regulatory submissions with local and central Indian food and drug authorities.
Collaborate cross-functionally to obtain new licenses and regulatory approvals, including support for importation of materials from Lonza global sites through required No Objection Certificates.
Establish, maintain, and update Drug Master Files (DMFs) for CHPL products with global authorities such as US FDA, Health Canada, and Chinese regulatory agencies.
Act as the primary regulatory contact for internal stakeholders (Quality, R&D, Business Development, Commercial, Marketing) and external customers, providing expert regulatory guidance.
Support regulatory audits and inspections, including preparation, authority interactions, and remediation activities, in close collaboration with Quality teams.
Partner with site and global Quality teams to assess regulatory impact of changes, deviations, and control strategies, ensuring ongoing compliance.
Deliver regulatory support to customers across the South Asia region, contributing to customer satisfaction, partnership programs, and strategic business initiatives.
Participate in relevant industry associations, conferences, and regulatory networks to maintain regulatory intelligence and professional expertise.
Support internal regulatory governance by prioritizing and organizing regulatory initiatives, coordinating workloads across teams, and developing clear regulatory instructions and guidance aligned with business objectives.

What We’re Looking For

Master’s degree (or equivalent experience) in Pharmacy, Chemistry, Biotechnology, Bioengineering, Food Technology, or a related scientific discipline.
5–10 years of advanced experience in regulatory affairs, quality, or compliance within the healthcare, pharmaceutical, nutrition, or food industries.
Strong knowledge of Indian and South Asian regulatory frameworks covering GMP manufacturing, product registrations, licensing, and commercial activities.
Solid understanding of quality management systems, GMP requirements, and regulatory compliance processes.
Proven ability to engage effectively with regulatory authorities and certification bodies.
Strong analytical, problem-solving, and organizational skills with the ability to manage multiple priorities.
Excellent written and verbal communication skills in English.
Ability to work independently with direction, while collaborating effectively across global and cross-functional teams.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world — and making a meaningful difference.

Reference: R72032

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