Job Description

Roles and Responsibilities

• DMF submissions, Annual Reports, Variations, Renewals etc. for US and Europe market.
• Compilation and publishing in eCTD/CTD format for Submission to health agencies like EDQM, USFDA etc.
• Oversee final technical quality review and technical validation (PDF/eCTD/NeeS)
• Review all regulatory agency submission materials for accuracy, comprehensiveness, or compliance with regulatory standards.
• Provide deficiencies responses to HA regulatory agencies for deficiencies and comments
• Evaluation of change controls for post-approval changes (PAC)
• Compilation, review and submission of Variations
• Keeping up to date with changes in regulatory legislation and guidelines
• Conduct Pre-submission and Initial Submissions meetings
• Preparation of gap analysis report of CMC regulatory submission including recommendations to facilitate the review of application by HA
• Gaps in manufacturing and controls, assessment of regulatory risk and strategy

• Providing gap analysis against applicable HA requirements and standards and communicate cross functional team to comply the samezCharacterization of the API and Raw materials used to manufacture the API
• Description of the product and process development
• Analytical methods and specifications used for testing
• Release and stability testing data for both the API
• Preparation of responses to HA,comment letters&assessment reports
• Initial assessment of the submission (initial / post approval submissions) E.g., initial validation comments, response to the completeness assessment report, response to the Information Requests

Ciel HR