Executive - Regulatory and Scientific Affairs

2 weeks ago

Ahmedabad, Gujarat, India Novumgen Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Role Overview:

Preparation, review, and submission of responses to deficiency letters raised by the UK/EU regulatory agencies during the evaluation of Marketing Authorisation Applications (MAAs). The role ensures high-quality and compliant responses in line with regulatory expectations and timelines.

Key Responsibilities:

  • Coordinate with cross-functional teams (Development, Clinical, Nonclinical, Pharmacovigilance, Quality, Manufacturing, etc.) to obtain required information and justifications.
  • Consolidate and review all data and documents to ensure consistency, accuracy, and regulatory compliance prior to submission.
  • Draft and review responses addressing concerns on quality, safety, and efficacy aspects.
  • Ensure alignment with regulatory guidelines (MHRA guidance, EU guidance, ICH guidelines, etc.).
  • Maintain consistency across the dossier.
  • Ensure all responses meet formatting and procedural requirements (e.g., eCTD structure, proper referencing, etc.).
  • Adhere to internal quality systems, SOPs, and regulatory documentation control procedures.

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