Parexel

Senior Regulatory Affairs Consultant

Parexel

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Senior

Tech Stack

Vault

About the role

  • Improve the world's health through regulatory consulting
  • Develop therapy that ultimately benefits patients
  • Maintain up-to-date knowledge about regulatory guidelines
  • Coordinate with stakeholders for documentation required for submissions
  • Deliver regulatory maintenance submissions from global and regional perspectives

Requirements

  • 11+ years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products
  • Good understanding of regulatory framework
  • Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions
  • Working knowledge of EU/US regulatory procedures
  • Knowledge of ROW markets regulatory legislations
  • Experience in handling CMC related health authority queries
  • Preparation / Review of Regulatory gap analysis and strategy documents
  • Authoring and review of CMC component of Marketing Authorization Applications & Variations
  • Evaluation of change controls and deviations
  • Co-ordination with internal and external stakeholders for documentation required for various submissions
  • Develop up-to-date knowledge about regulatory guideline updates
  • Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault
  • Strong communications skills and ability to guide and mentor team members
  • Ability to work independently
  • Authoring content of the drug product label
  • Familiarity with EU Guidelines for QRD / Excipients
  • Artwork management for countries with label in English.
Benefits
  • Health insurance
  • Flexible work arrangements
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
life cycle managementregulatory maintenance submissionsregulatory gap analysisMarketing Authorization ApplicationsCMC component authoringchange controls evaluationregulatory framework understandingEU/US regulatory proceduresCMC related health authority queriesregulatory guideline updates
Soft Skills
strong communication skillsability to guide and mentorindependent work