BriefCase
BriefCase

Manager - Corporate Regulatory Affairs Job in Piramal Enterprises Ltd.

Manager - Corporate Regulatory Affairs

Piramal Enterprises Ltd. 4+ weeks ago
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Job Summary

Description

  • Compilationand submission of Abbreviated New Drug Applications (ANDAs) in CTD format forUS and other markets as per respective regulatory requirements
  • Compilationof responses pertaining to CMC, Dissolution, Bioequivalence, Microbiology andLabeling deficiencies and ensuring that registration approvals are grantedwithout undue delay
  • Labeling,SPL and drug listing activities
  • Reviewand approval of submission related documents such as Batch ManufacturingRecords, Packaging Records, Analytical Reports, Stability reports, Technologytransfer documents
  • Draftingcontrolled correspondences to USFDA
  • Duediligence of products planned for acquisition
  • Knowledge-sharingwith stakeholders like Plant, R&D on latest requirements of regulatorybodies aiming to achieve quality filings and product approval within thedefined timelines (e.g. ANDA GDUFA goal dates)
  • Identifyingthe appropriate filing category for post approval changes and submissions toUSFDA
  • Preparationof regulatory strategy documents
  • Providingregulatory costing for new projects
  • Participationin site audit/inspection, when scheduled
  • Lifecyclemanagement of approved products
  • Database management


Qualification :

Qualifications


Minimum 8+ years of experience in Regulatory Affairs with primary focus in regulated markets for US, EU and Canada

Well versed in ANDA filings, drafting deficiency responses and eCTD requirements

Expertise in submissions of various dosage forms with primary focus on OSDs and Injectables

Hands-on experience in eCTD submissions (Compilation/ Publishing/ Drug Listing)

Knowledge of current regulatory requirements and guidelines

Strong verbal and written communication skills
Experience Required :

Fresher

Vacancy :

2 - 4 Hires

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