Regulatory Affairs Specialist

7 days ago


Mumbai, Maharashtra, India Inventia Healthcare Limited Full time
Job Summary

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to play a key role in preparing and submitting regulatory documents for US, EU, UK, and Emerging Markets, ensuring compliance with all relevant guidelines and regulations.

This role requires strong communication skills, attention to detail, and the ability to collaborate with various departments to achieve successful submissions.

Key Responsibilities
  • Regulatory Submissions: Prepare and submit regulatory documents for US, EU, and UK markets.
  • Handle Submissions for Emerging Markets: Handle submissions for Emerging markets including MENA and GCC countries.
  • Ensure Compliance: Ensure compliance with eCTD publishing standards.
  • Guidelines and Compliance: Stay updated and well-versed in ICH guidelines and ASEAN CTD requirements.
  • Document Preparation and Review: Participate in the finalization of data for submission.
  • Review and Prepare Documents: Review and prepare documents required for submission in dossiers, including specifications, methods of analysis, analytical method validation protocols and reports, stability protocols and reports, process validation protocols and reports, master batch records, and PDRs.
  • Quality by Design (QbD): Apply the QbD approach to product development.
  • Regulatory Inputs and Clearances: Provide necessary regulatory inputs and clearances during product development to the product development team (PDT).
  • Post-Approval Submissions: Manage post-approval submission processes including variation filings, supplement filings (CBE0, CBE-30, PAS), and annual reports.
  • Interdepartmental Collaboration: Maintain effective communication, both written and oral, with R&D, CQA, QA, and Plant departments.
Qualifications
  • Bachelor's Degree: Bachelor's degree in a related field (Pharmacy, Chemistry, Biology, or a related scientific discipline).
  • Regulatory Experience: Proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets.
  • Regulatory Knowledge: In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing.
  • Document Preparation: Hands-on experience with regulatory document preparation and review.
  • QbD Principles: Strong understanding of QbD principles and ability to analyze trend data.
  • Communication Skills: Excellent communication and collaboration skills.
  • Organizational Skills: Detail-oriented with strong organizational skills.
  • Project Management: Ability to work independently and manage multiple projects simultaneously.


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