Job Opening in Regulatory Affairs at Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Sr Mgr, Regulatory Affairs
Tracking of online submissions, query responses & approvals for medical devices applications & Import and registration division applications on SUGAM portal
Key Accountabilities and Responsibilities
Establish strong relationship with country regulatory authorities to facilitate technical and strategic discussions related to product.
• Monitoring of country regulatory changes and assessment per their impact on current product portfolio.
• Build strategies for country regulatory changes and communicate to Global and country cross functional teams.
• Ensure product life cycle management for all registered products in India & adjoining countries. To ensure timely closure of all labelling changes (with global) per se India specific labelling requirements and creation of local labels with India specific requirements for devices prior to custom clearance and commercialization
• Responsible for change control assessment from regulatory perspective and timely reporting of post approval changes to respective regulatory authorities.
• Timely filing of product recalls/complaints notification as per SOP to regulatory agency.
• Responsible for timely release of port consignments (Air and Sea) for commercialization of product to meet business demands.
• Responsible for timely release of batches from NIB to support business to cater tender requirements.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Participate in the development or implementation of clinical trial protocols
Location : Gurgaon, HR IN
Industry Type : Pharma/ Healthcare/ Clinical research
Job Category : Communications
Req #: JR - 017612
Functional Area : Regulatory Affairs
End Date : 20th May, 2020
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