Regulatory Affairs Professional

17 hours ago


Surat, Gujarat, India beBeeCompliance Full time ₹ 60,00,000 - ₹ 1,20,00,000

Job Title:

Regulatory Compliance Specialist

Job Description:

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.

Our team requires an individual with exceptional organizational skills to manage and prepare Variation documents, evaluate post-approval CMC changes in compliance with global regulatory requirements.

This role involves contributing to Lifecycle Management activities by compiling and reviewing CTD dossier modules, as well as providing regulatory strategies and conducting evaluations of post-approval CMC changes considering ICH and country-specific guidelines.

The successful candidate will be responsible for managing compilation and submission of variations/supplements for multiple countries, utilizing Veeva Vault RIM to track queries and manage submission workflows.

Additionally, the chosen candidate will review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.

Required Skills and Qualifications:
  • Minimum 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Hands-on experience in initial dossier compilation for multiple countries (Module 2 & 3).
  • Proficient in ICH guidelines and regulatory guidelines for various countries.
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.
  • Veeva Vault RIM proficiency is mandatory.
Benefits:

The selected candidate will have the opportunity to work in a dynamic environment with a talented team of professionals.

They will be provided with ongoing training and development opportunities to enhance their skills and expertise.



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