Specialist- Regulatory Affairs

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Your Role:

We are looking for a Regulatory Management Specialist to support regulatory compliance, advocacy, and market access activities in India.

• This role will work across internal and external stakeholders to monitor regulatory changes, support product submissions maintain compliance documentation, and represent India regulatory priorities in cross-functional and global discussions.
• Monitor and analyze regulatory guidelines, notifications, and gazettes issued by relevant authorities, and assess their impact on business operations
• Establish and maintain effective working relationships with key regulatory and government authorities, including CDSCO, IPC, DBT, DAHD, BIS, AQCS, DCPC, and relevant ministries
• Drive regulatory engagement and advocacy through active participation in industry associations, including providing input on draft guidelines, seeking clarifications on revised regulations, and addressing compliance gaps proactively
• Support regulatory submissions, including import license, test license, NOCs for API, excipients, chemicals, animal by products, cell lines, audits, and compliance documentation
• Support new product launches by determining product classification and identifying the most efficient and compliant regulatory pathway
• Collaborate cross-functionally to obtain documentation and justifications required for product import, registration, and regulatory query responses
• Ensure compliance with applicable standards and regulatory requirements, including WHO-GMP, GLP, Schedule M, and other relevant checklists
• Develop, review, and maintain Standard Operating Procedures for the regulatory function
• Provide technical and regulatory support to customers and internal stakeholders
• Represent India regulatory interests in global regulatory meetings and provide insight on Indian regulatory requirements.

Who You are

• Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline
• Strong understanding of Indian and global regulatory requirements, including CDSCO, IPC, DBT, DAHD, USFDA, EMA, IPEC, PDA and other relevant regulatory or industry bodies
• Experience handling regulatory submissions, audits, compliance documentation, and product registration or import-related activities
• Good understanding of Pharma and Biopharma manufacturing processes and unit operations
• Good understanding of regulatory pathways for new product introduction and lifecycle support such as - API, excipients, chemicals and animal by products, biological origin products etc.
• Experience engaging with regulatory authorities, government bodies, or industry associations is preferred
• Strong organizational skills and ability to manage multiple priorities in a dynamic environment
• Strong written and verbal communication skills
• Ability to work effectively in cross-functional teams and influence stakeholders across functions
• Willingness to travel domestically up to 10–15%.
• Proactive ownership of regulatory topics and timely follow-through on actions.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!