Regulatory Affairs Specialist

1 month 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 including MENA and GCC countries.
  • Ensure compliance with eCTD publishing standards.
  • Guidelines and Compliance:
  • Stay updated and well-versed in ICH guidelines and ASEAN CTD requirements.
  • Conduct thorough scientific and regulatory reviews of master documents to ensure compliance with all appropriate regulations.
  • Document Preparation and Review:
  • Participate in the finalization of data for submission.
  • 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.
  • Analyze trend data to support product development and submission processes.
  • 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.
  • Handle variation filing and renewal dossier submissions for Emerging markets.
  • Interdepartmental Collaboration:
  • Maintain effective communication, both written and oral, with R&D, CQA, QA, and Plant departments.
  • Gather and compile all required documents related to dossier submission.
  • Other Regulatory Knowledge:
  • Understand and manage CoPP application, manufacturing license, and registration sample requirements.
  • Knowledge of GMP applications required for dossier submission.
  • Task Management:
  • Willingness to work on assigned tasks as per company requirements.
Qualifications:
  • Bachelor's degree in a related field (Pharmacy, Chemistry, Biology, or a related scientific discipline).
  • Proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets.
  • In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing.
  • Hands-on experience with regulatory document preparation and review.
  • Strong understanding of QbD principles and ability to analyze trend data.
  • Excellent communication and collaboration skills.
  • Detail-oriented with strong organizational skills.
  • Ability to work independently and manage multiple projects simultaneously.

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