Job Title: Freelance Regulatory Expert – ANDA Dossier Review
Location: Remote | India (Freelance)
Employment Type: Contract / Freelance
Job Category: Regulatory Affairs | ANDA Dossier Review | USFDA Compliance | Pharmaceutical Submissions
Experience Required: Minimum 5 years of hands-on experience in regulatory affairs, ANDA dossier preparation, and USFDA submissions
About the Company
Pharmazone is a leading pharmaceutical consulting company collaborating with global clients on regulatory submissions, dossier management, and compliance advisory services. Pharmazone focuses on providing expert guidance to accelerate drug approvals and ensure regulatory compliance across global markets.
Role Overview
Pharmazone is seeking experienced Freelance Regulatory Experts to support a global client in technical and regulatory review of ANDA dossiers. The ideal candidate will have proven expertise in regulatory affairs, ANDA documentation, and USFDA submission requirements. This is a remote freelance opportunity for professionals seeking flexible engagement while contributing to high-impact pharmaceutical projects.
Key Responsibilities
Conduct comprehensive review and assessment of ANDA dossiers for technical and regulatory compliance
Prepare responses to regulatory queries from USFDA and other regulatory agencies
Ensure all submissions meet USFDA regulatory expectations and submission standards
Collaborate with Pharmazone and client teams to maintain accurate and compliant documentation
Provide expert guidance on regulatory strategies for ANDA approval
Required Experience & Skills
Minimum 5 years of hands-on experience in ANDA dossier preparation and regulatory affairs
Strong knowledge of USFDA regulatory requirements and submission processes
Experience in handling regulatory queries and preparing high-quality responses
Detail-oriented, organized, and able to work independently
Excellent communication skills in English, both written and verbal
Educational Qualifications
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or related discipline
How to Apply
Interested candidates can share their updated CV or profile at hr@pharmazones.com with details of experience, areas of expertise, and availability.
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