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Position: Senior Executive, Regulatory Affairs

Location: Chennai, Tamil Nadu

Job Description:

  • Functions as Regulatory support for Biosimilars development projects and the lifecycle changes work with Global Product Owners (GPOs), cross-functional teams, local and regional regulatory colleagues, external partners (in case of in-licensed products) and  Global Health Authorities (US and Ex-US) to frame and drive global regulatory strategies and Global submissions.
  • Manages the preparation and maintenance of core dossiers for original applications and subsequent changes and coordinates responses to deficiency letters, with the assistance of local and regional regulatory colleagues.
  • Provides adequate support and guidance to the team for authoring regulatory submissions and ensures effective data presentation and quality.

  • The author with team members, key pieces of regulatory submissions on need basis.
  • Advices Biosimilars programs on the regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, cross-functional teams, and external partners to ensure regulatory data requirement and the deliverable dates are met.
  • Negotiates submission data requirements and deliverable dates with regulatory authorities on a need basis.
  • Remains knowledgeable and maintains awareness about current regulations and guidance related to Biosimilars, interprets, assesses its impact on product development programs, and communicates to necessary stakeholders.
  • Drives resolution of issues. Communicates issues, impact, and outcomes to global regulatory management and core team.
  • Responsible for effective coordination and collaboration with the regional regulatory leads to ensure key submission deliverables assigned to the regional group.
  • Responsible for ensuring compliance of the team to the submission standards, procedures, and policies framed by Global Regulatory Affairs.
  • Suggests supports and implements system improvements to ensure regulatory compliance, reduce cycle time, and create efficiency.

Qualification: B.Pharma, M.Pharma

Experience: Not Defined

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