Danaher Corporation RA Manager in New Delhi, India
Define solid RA strategy and plan based on deep understanding of the regulatory environment and business dynamics and ensure flawless execution of all local regulatory compliance requirements for India & SWA.
Management of timely New Product Registrations & Renewal Approvals for India & SWA Region.
Lead and coordinate with RA team locally and with the manufacturers / legal manufacturer for documents required for timely product registration (New Product/Renewal registration/ Post Approval changes/ Product Life Cycle Maintenance & any other notification) and ensure 100% on time submissions to the national authority as per the current regulations in place (completion of KPIs and metrics).
Lead and coordinate all changes in the regulatory requirements and timely. Preparation of impact assessments as well as presentation to Global regulatory council.
Review/ coordinate the review and approval promotional / marketing materials
Manage the post market activities.
Provide regulatory intelligence and manage internal process to share regulatory landscape change and drive needed attention and action from internal stakeholders
Lead interactions with regulatory authorities related to regulation, policies, guidelines, and QMS requirements
Support business initiatives regarding maintaining business base and enabling new business growth opportunities
Leading, Developing and Mentoring RA team as a high-performing organization
Track emerging issues and identify solutions with sense of urgency and business acumen
Representing organization in trade associations, 3rd party organization, governmental groups to advocate company and seek policy shaping opportunities
Train local staff on pre-market regulatory requirements and post market regulatory requirements and processes
Develop and implement/improve local regulatory procedures and work instructions for regulatory processes.
Manage and approve the preparation of RA procedures for EMEAI as requested.
Represent the department in all internal and external audits related to regulatory processes.
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