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パレクセルでの仕事

パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Senior Regulatory Affairs Associate

求人ID R0000039988 ロケーション インド 仕事内容

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. A Senior Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations.

  • EU Single/Workshare/Supergrouped Variation for CP and MRP (N&R and Established products) and HAQ support

  • Coordination of kick-off meeting and any other meeting and follow-ups

  • Reg Vault: creation of RO & SO and Submission content plan

  • Drafting of Cover Letter, Application forms

  • Navigating PLM portal for EU Application form Generation

  • Stakeholder Management

  • Finalization of submission content plans

  • Publishing request and QC of publishing output

  • Managing HA correspondences in Reg Vault

    Shift: 12 pm to 9 pm IST

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