Regulatory Affairs Consultant

2 days ago

Bengaluru, Karnataka, India Parexel Full time ₹ 12,00,000 - ₹ 24,00,000 per year

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

  • Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets, mainly US and EU.
  • 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.
  • Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage.
  • Experience in handling CMC related health authority queries, and author responses to HA requests.
  • Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
  • Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
  • Authoring CMC component for marketed products, of Annual Reports, Variations, Renewals in EU (Type IA/IB/II/IAIN), and US and RoW markets.
  • Evaluation of change controls and deviations and identification of required documentation and strategy for EU/US submissions and other markets.
  • Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.
  • Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
  • 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
  • Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
  • Authoring content of the drug product label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
  • Familiarity with EU Guidelines for QRD / Excipients.
  • Artwork management for countries with label in English.

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