Mgr, Quality (Gurugram)

Mgr, Quality (Gurugram)

20 Aug
|
BAXTER
|
Gurugram

20 Aug

BAXTER

Gurugram

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

📌 Mgr, Quality (Gurugram)
🏢 BAXTER
📍 Gurugram

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