Regulatory Affairs Specialist

7 days ago


Mumbai, Maharashtra, India Piramal Group Full time

Business: Piramal Critical Care

Department: Regulatory Affairs

Location: Kurla, Mumbai

Travel: Low

Job Overview

To manage regulatory filings for Europe with minimal supervision, ensuring compliance with eCTD requirements.

Key Stakeholders: Internal
  • Country Manager
  • Plant
  • QA
  • Artwork Department
  • Supply Chain
  • PV
Key Stakeholders: External
  • Health Authorities
  • Distributors
Reporting Structure

Reports into the Manager-Regulatory Affairs

Experience

Minimum 2 years of relevant experience in handling Europe market. Overall total experience in Regulatory of 5 years

Competencies:
  • Good communication skills in English
  • Proficient in using Excel sheets, PowerPoint, etc.
  • Ready to take challenges in work
  • Ready to move to different locations for work as and when required
  • Ability to coordinate intra and inter department and across sites globally
  • Good at reviewing documents and having good technical knowledge
  • Ability to multitask

Key Roles & Responsibilities:

Under the guidance of the Team Leader, this person should be able:

  • To submit the product registration dossier of assigned products to targeted countries in Europe as per eCTD requirements.
  • To file all the required variations and Renewals of assigned products in line with guidelines and checklists as per the plan.
  • To respond to queries received from regulatory agencies, business unit or other stakeholders by ensuring complete and accurate information is provided within predefined timelines.
  • To review product labeling updates in EU.
  • To maintain various databases in a timely manner.
  • To update himself/herself with the relevant current EMEA, National, and ICH guidelines and requirements.
  • To provide required support to Pharmacovigilance team as and when required.
  • To ensure support in execution of any projects assigned as per business need.


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