Global Market Submission Specialist

17 hours ago


Davangere, Karnataka, India beBeeRegulatoryAffair Full time ₹ 12,00,000 - ₹ 16,00,000

Job Title:

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We are seeking a detail-oriented professional to support global market submissions.

Description:

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This role involves preparing documents and evaluating changes in compliance with global regulatory requirements.

Key Responsibilities:

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  • Prepare variation documents and/or evaluate post-approval CMC changes.

  • Contribute to lifecycle management activities by helping to compile and review CTD dossier modules.

  • Compile initial dossiers for US / EU / SA / WHO / ANZ / Other Countries.

  • Provide regulatory strategies and conduct evaluations of post-approval CMC changes.

  • Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.

  • Utilize Veeva Vault RIM to track queries and manage submission workflows.

  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process & analytical validations, batch analysis data, and stability data.

Requirements:

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  • Bachelor's degree in Life Sciences or related field

  • Certification in Regulatory Affairs is preferred but not required

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Experience Requirement:

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  • 3+ years of experience in managing Initial submissions, Variations, and full Lifecycle Management (LCM) deliverables for the global markets.

  • Must have experience with Veeva Vault RIM

  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries.

  • Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other countries (Module 2 & 3).

  • Experience in providing Regulatory strategies/ Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.

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Benefits:

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Opportunity to work on global market submissions and contribute to regulatory strategies.

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What We Offer:

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A dynamic work environment and opportunities for growth and development.



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