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 current 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 qu