Manager – Regulatory Affairs (Pharma), India

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.

Want to help us make a difference?
Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.
Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.

To meet our challenges, we are looking for a Manager – Regulatory Affairs (Pharma), India within the Regulatory Affairs team! This position will be located in Mumbai.

Their mission?
The Manager of Regulatory Affairs supports the development and execution of regulatory strategies to ensure timely approval, manages regulatory submissions, and ensures compliance with global regulations and life cycle management of products. The role focuses on interactions with Indian regulatory authorities, primarily the Central Drugs Standard Control Organization (CDSCO), and supports business objectives while ensuing adherence to applicable laws, regulations and guidelines. This role involves cross-functional collaboration and may or may not include mentoring junior team members.

Your experience and talents will make the difference to:

Strategy & Compliance:

• Contribute to global/regional regulatory strategies for new product registrations, variations, renewals, and lifecycle management.
• Liaise with local regulatory agencies to support submission planning and execution.
• Act as the primary point of contact with Indian Regulatory authorities including CDSCO and State FDA Offices.
• Monitor regulatory trends, provide regulatory intelligence on changes in Indian Regulations, guidelines, and policies, and support adaptation of internal processes.

Operations:

• Lead preparation and submission of regulatory filings to CDSCO and State Licensing Authorities, including NDA, CTA, Import/Manufacturing License Applications, Variations, renewals and amendments.
• Ensure timely responses to regulatory queries.
• Maintain regulatory documentation systems aligned with global standards.
• Track submission timelines and ensure timely regulatory approvals.
• Prepare regulatory status reports and updates for internal stakeholders and senior management.

Collaboration:

• Work closely with Global Regulatory Affairs, R&D, Quality, Clinical, and Commercial teams to ensure regulatory requirements are met.
• Support product launches and changes from a regulatory perspective.
• Provide regulatory input for business development, licensing, or partnership activities related to India.
• Support KPI tracking and continuous improvement initiatives.

Mentorship:

• Provide guidance to junior colleagues and support knowledge sharing across teams.

What we will love about you:

• In-depth knowledge of Indian regulatory requirements, including Drugs and Cosmetics Act and Rules.
• Strong understanding of regulatory submission processes and timelines in India.
• Strong communication and organizational skills.
• Ability to work independently and manage multiple priorities.
• Strong stakeholder management and cross-functional collaboration skills.

And also … ​

• Bachelor’s or Master’s in Life Sciences, Pharmacy, or related field. Advances degree (Master’s/PhD) is an advantage.
• 5-8 years of regulatory affairs experience in pharma, biotech, or medical devices with strong hands-on expertise in India regulatory affairs.
• Demonstrated experience managing submissions and interactions with CDSCO.
• Familiarity with FDA, EMA, and international regulatory frameworks.

If you identify yourself in this position, please apply by uploading your resume and let's start the journey together!

Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. 

Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws.
 

As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach.

To find out more about our products, values and sustainable development ambitions visit us at www.roquette.com and at www.sustainability.roquette.com