Sr. Officer Regulatory Affairs

4 days ago


Dombivli, Maharashtra, India LYWO RECRUITMENT CONSULTING Full time ₹ 4,00,000 - ₹ 8,00,000 per year

Roles & Responsibilities

Regulatory Submissions & Filings

  • Prepare, review, and submit DMFs, CEPs, and regulatory dossiers for API registration in global markets (USFDA, EMA, WHO, etc.).
  • Ensure submissions are complete, accurate, and in CTD/eCTD format.
  • Coordinate with internal teams to gather technical and manufacturing data for filings.
  • Track submissions, approvals, and queries from regulatory authorities and ensure timely responses.

Dossier Preparation & Maintenance

  • Prepare and maintain dossiers in compliance with current regulatory standards and GMP requirements.
  • Update existing dossiers to reflect process or analytical changes.
  • Review and compile CMC (Chemistry, Manufacturing & Controls) documentation.
  • Ensure accurate electronic storage and document retrieval systems.

Regulatory Compliance & Standards

  • Monitor global regulatory changes and implement updates as required.
  • Support development of regulatory strategies for product approvals.
  • Participate in regulatory inspections, audits, and internal compliance reviews.
  • Ensure continuous adherence to international pharmaceutical regulations.

Documentation & Control

  • Ensure compliance with Good Documentation Practices (GDP).
  • Maintain regulatory databases, archives, and document control procedures.
  • Prepare and review regulatory reports, summaries, and submissions.
  • Safeguard the integrity and completeness of all regulatory documentation.

Collaboration & Communication

  • Liaise with external regulatory consultants, agencies, and internal teams (R&D, QA, QC, Production).
  • Provide regulatory guidance for product and process changes.
  • Present updates and regulatory insights to management.
  • Participate in meetings, audits, and conferences related to regulatory affairs.

Risk Assessment & Mitigation

  • Identify potential regulatory risks and conduct impact assessments.
  • Develop and implement mitigation strategies to ensure compliance.
  • Monitor regulatory trends to anticipate and address emerging challenges.


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