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Regulatory Affairs Consultant

2 months ago

India Parexel Full time

Regulatory Affairs Consultant:


  • Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) in various markets.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
  • Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
  • Responsible for managing (Authoring and Review) of biologics/biosimilar/vaccine investigational product submission such as IND & IMPD for USFDA, EMA
  • Authoring, review, and submission of BLA/MAA dossiers for US/EU/ROW /India markets
  • BLA authoring and also post approval submissions for Biosimilar.
  • Preparation of regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, CTA, BMF, BLA, NDA, and MAA applications.
  • Life cycle management (LCM) for approved products. (annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN)
  • Evaluation of change controls and deviations and defining regulatory strategy
  • Preparation and submission of scientific advice, briefing book, Type 2 meeting packages for USFDA and EMA
  • Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible
  • Develop up-to-date knowledge about regulatory guidelines and applies regulatory requirements and their impact on submissions.
  • Working experience in Regulatory Information Management Systems like Veeva Vault.
  • Strong communications skills and ability to guide and mentor team members.
  • Ability to work independently.