Regulatory Affairs Manager

Roles & Responsibilities:

• Lead regulatory surveillance for South Asia (India, Pakistan, Bangladesh, Bhutan, Nepal, Sri Lanka) and monitor regulatory changes
• Ensure compliance of Capsules & Health Ingredients (CHI) product portfolio with regional regulations
• Act as primary regulatory interface with Indian food and drug authorities
• Manage facility and product registrations, licenses, and regulatory submissions
• Support new licenses, approvals, and importation activities including NOCs
• Prepare, maintain, and update Drug Master Files (DMFs) with global authorities (US FDA, Health Canada, China, etc.)
• Collaborate with Quality, R&D, Commercial, and Global teams on regulatory matters
• Support regulatory audits and inspections, including preparation and remediation
• Assess regulatory impact of changes, deviations, and control strategies
• Provide regulatory guidance to customers and support business growth initiatives
• Participate in industry associations and regulatory forums to maintain regulatory intelligence

Qualification:

• Master’s degree (or equivalent) in Pharmacy, Chemistry, Biotechnology, Bioengineering, Food Technology, or related scientific discipline

Experience:

• 5-10 years of experience in Regulatory Affairs, Quality, or Compliance
• Experience within pharmaceutical, healthcare, nutrition, or food industries preferred

Skills:

• Strong knowledge of Indian and South Asian regulatory frameworks
• Sound understanding of GMP, quality systems, and compliance processes
• Experience dealing with regulatory authorities and certification bodies
• Strong analytical, problem-solving, and organizational skills
• Excellent written and verbal communication skills in English
• Ability to work independently and collaborate with global cross-functional teams

About the Company:
Lonza is a global leader in life sciences, operating across five continents. The company partners with the pharmaceutical, biotech, and nutrition industries to deliver innovative solutions that improve health and quality of life. Lonza is committed to ethical practices, sustainability, and empowering its people to build impactful careers while making a meaningful difference worldwide.