
DDReg Pharma is a global life sciences consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services. With over 15 years of experience, they help pharmaceutical,…

DDReg Pharma is a global life sciences consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services. With over 15 years of experience, they help pharmaceutical,…
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Job Purpose DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. The role involves preparation of complex CTD modules, quality control of submissions, gap analysis, and support in responding to regulatory queries. The ideal candidate will collaborate cross-functionally and support team development and process improvement.
Key Responsibilities
— Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview)
–Regulatory strategy reports
–SPC, PI, PIL, RMP
–Compiled modules for small molecules and biosimilars
–SPL, BE templates, TIF
–Aggregate reports, Expert reports
Key Skills & Requirements
Why Join Us
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