Sr Spec - Quality & Regulatory Affairs

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 requirements and established timelines. Support regulatory submissions, authority queries, approvals, and post-approval activities with Indian health authorities through applicable systems such as SUGAM. Perform regulatory assessments of product, manufacturing, labeling, artwork, supplier, and site changes to determine regulatory impact and submission strategies. Maintain product registrations and regulatory approvals by ensuring timely completion of renewals, post-approval changes, commitments, and regulatory notifications. Monitor changes in regulatory requirements, industry trends, and communicate relevant risks and potential business impacts to internal stakeholders. Liaise with health authorities, distributors, license holders, and external regulatory partners to support product registrations, approvals, 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.