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.
- Gap Analysis
- Perform gap assessment for small molecules and biosimilar products.
- Evaluate non-clinical and clinical data provided by clients to identify deficiencies affecting product submission/approval.
- Draft structured gap reports/sheets and propose corrective actions.
- Query Response & Literature Support
- Support regulatory query responses by evaluating existing documents and addressing authority/client questions.
- Conduct literature searches to update documentation and prepare query response reports as required.
- Work with cross-functional teams to ensure clarity and customer satisfaction.
- Mentoring & Training
- Support resolution of technical/medical doubts raised by team members.
- Provide on-the-job training and guidance to direct reportees.
- Identify training needs for self and team on a quarterly basis.
Key Skills & Requirements
- Bachelor’s/Master’s/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
- 3–7 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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