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

• Authoring & Review of Regulatory Documents
• Draft high-quality medical and regulatory documents in accordance with global guidelines.
• Prepare complex regulatory documents such as:

— Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview)

–Regulatory strategy reports

• Ensure consistency, scientific accuracy, and regulatory compliance across documents.
• Quality Control (QC) of Documents
• Perform QC review of simple and complex documents including:

–SPC, PI, PIL, RMP

–Compiled modules for small molecules and biosimilars

–SPL, BE templates, TIF

–Aggregate reports, Expert reports

• Ensure documents are delivered with high quality and within agreed timelines.

Key Skills & Requirements

• Bachelor’s/Master’s/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
• 7–10 years of experience in regulatory/medical writing.
• Strong understanding of CTD format and global regulatory guidelines (ICH, FDA, EMA, CDSCO).
• Hands-on experience in: –Module 2 documents –Data analysis for gap assessment –QC of regulatory deliverables
• Excellent written communication, analytical skills, and attention to detail.
• Proficiency in MS Office and documentation systems.

Why Join Us

• Opportunity to contribute to key regulatory submissions
• Exposure to global health authority expectations
• Skill development and continuous learning environment
• Collaborative work culture

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