About the role
- Prepare and execute regulatory submissions, renewals, variations, and lifecycle management activities for assigned pharmaceutical and medical device product portfolios in India, while supporting regulatory activities for Bangladesh and Sri Lanka.
- Compile, review, and submit regulatory dossiers, authority responses, and supporting documentation in accordance with local regulatory requirements and established timelines.
- Support regulatory submissions, authority queries, approvals, and post-approval activities with Indian health authorities, including medical device, pharmaceutical, import, and registration applications through applicable regulatory systems and portals such as SUGAM.
- Perform regulatory assessments of product, manufacturing, labeling, artwork, supplier, and site changes to determine regulatory impact, reporting requirements, and submission strategies.
- Maintain product registrations and regulatory approvals by ensuring timely completion of renewals, post-approval changes, commitments, regulatory notifications, and lifecycle management activities.
- Monitor changes in regulatory requirements, regulatory intelligence, and industry trends, and communicate relevant risks, requirements, and potential business impacts to internal stakeholders.
- Liaise with health authorities, distributors, license holders, and external regulatory partners to support product registrations, regulatory approvals, regulatory queries, and compliance activities.
- Review and support approval of product labeling, artwork, promotional materials, and regulatory documentation to ensure compliance with applicable local regulations and Baxter requirements.
- Support health authority inspections, regulatory audits, recalls, and responses to regulatory queries, observations, and commitments in collaboration with cross-functional stakeholders.
- Collaborate closely with Global Regulatory Affairs, Quality, Supply Chain, Commercial, Marketing, Medical Affairs, and external partners to support regulatory submissions, product launches, lifecycle management activities, compliance initiatives, supply continuity, and business objectives.
- Other duties as assigned.
Education and/or Experience:
- Bachelors Degree in Pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline.
- Minimum 5 years of Regulatory Affairs experience within the pharmaceutical, medical device, biologics, nutrition, or healthcare industry, including product registrations, lifecycle management, regulatory assessments, and health authority interactions.
- Experience supporting regulatory activities in India and working with distributors, license holders, or regulatory partners across South Asia is preferred.
- Experience using Regulatory Information Management Systems (RIMS), TrackWise, SUGAM, and other regulatory management tools is preferred
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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