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Senior Specialist, Regulatory Affairs

Senior Specialist, Regulatory Affairs

ConfidentialNoida
4 days ago
Job description
  • Labeling Specialist responsible for Pre-evaluation of Reference Country Strategies, Deviation creation, Pre-evaluation of DLs, CCDS Update process till Global Dispatch, Binder creation, Attending Product PET meetings, Literature search , GLS QA check for Labeling Deviations Dashboard, Internal GLM meetings, Labeling Support, Pre-Evaluation of Prior Submission Deviations, Internal QA Check of Global Labeling documents, Drafting of Global Response Documents, Drafting of PET Meeting Minutes and PET Written Reviews, Email Archiving activities.
  • Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
  • Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
  • Support with preparation, review and compilation of documents within the framework of regulatory affairs projects.
  • Communicate with clients and Health Authorities in close cooperation with the respective lead.
  • Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
  • General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
  • Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
  • Support with VDC strategy implementation and optimization.
  • Comply with and support the maintenance of internal procedures.
  • Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead.

    • Qualification & Experience

    • 3-5 years of experience, or demonstrable capability, in area of responsibility or similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks.
    • University degree in Life Science.

      • Skills Required

    • Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.
    • Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.
    • Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
    • Ability to train and support junior / new colleagues in daily activities; ability to lead small projects with clearly defined scope.
    • Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as clients team lead level.
    • Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance

      • Skills Required

      glm , Vdc, Microsoft Excel

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    Regulatory Specialist • Noida