About the role
Develop and execute regulatory strategies for product registrations, renewals, variations, lifecycle management activities, and maintenance of existing product licenses across India, while providing regulatory oversight and support for Bangladesh and Sri Lanka.
Lead and oversee regulatory submissions, authority queries, approvals, and post-approval activities with health authorities, including management of medical device, pharmaceutical, import, and registration applications through applicable regulatory systems and portals such as SUGAM, ensuring timely approvals and compliance with local regulatory requirements.
Establish and maintain effective relationships with health authorities, distributors, license holders, and external regulatory stakeholders to facilitate successful regulatory outcomes.
Lead regulatory support for health authority inspections and regulatory audits, coordinate responses to regulatory observations and commitments, and ensure timely implementation of corrective actions in collaboration with cross-functional stakeholder.
Monitor and assess evolving regulatory requirements, regulatory intelligence, and industry trends across India, Bangladesh, and Sri Lanka; evaluate business impact and drive implementation of appropriate regulatory strategies to ensure continued compliance and business growth.
Ensure effective product lifecycle management for registered products by performing regulatory assessments and change control evaluations, determining regulatory impact and reporting requirements, implementing labeling and regulatory changes, and ensuring timely submission of post-approval changes, renewals, variations, and regulatory commitments to health authorities.
Provide regulatory oversight, guidance, and support to distributors and local representatives to ensure timely execution of registrations, renewals, variations, regulatory notifications, and compliance obligations.
Support commercialization initiatives, product launches, portfolio expansion, importation, and supply continuity activities by providing regulatory assessments and recommendations.
Review and approve labeling, artwork, promotional materials, and regulatory documentation to ensure compliance with applicable local regulations and Baxter requirements.
Represent Regulatory Affairs on cross-functional project teams and collaborate with Global Regulatory Affairs, Quality, Commercial, Supply Chain, Marketing, and other stakeholders to achieve regulatory and business objectives.
Lead, develop, and provide guidance to Regulatory Affairs team members, fostering technical competency, regulatory excellence, employee development, and effective execution of business and regulatory objectives.
Other assigned tasks
Qualifications:
Strong knowledge of India and South Asia regulatory requirements and registration processes, including experience with CDSCO regulations, regulatory submissions, approvals, lifecycle management activities, and regulatory systems such as SUGAM.
- Strong leadership, project management, communication, stakeholder management, and negotiation skills, with the ability to lead teams, manage complex regulatory projects, identify compliance risks, and effectively collaborate within a matrix and multicultural environment.
Education and/or Experience:
- Bachelor's degree in pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline.
- Minimum 7 years of Regulatory Affairs experience within the pharmaceutical, medical device, biologics, nutrition, or healthcare industry.
- Experience in product registrations, lifecycle management, and health authority interactions.
- Experience managing regulatory activities across India and working with distributors, license holders, or regulatory partners across South Asia in a multinational environment is preferred. Experience using Regulatory Information Management Systems (RIMS), TrackWise, 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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