Managing Partner at HR INDIA SOLUTIONS
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Regulatory Medical Writer - eCTD/DMF Submissions (6-10 yrs)
Job Overview:
We are seeking a detail-oriented and experienced Regulatory Medical Writer with expertise in eCTD submissions and Drug Master File (DMF) documentation. The primary focus is on Module 2 and 3 (quality), but it is a plus if the candidate can also support the preparation of non-clinical (Module 4) and clinical (Module 5) documents, such as summaries and overviews for global submissions.
This role collaborates with global teams to deliver high-quality, submission-ready documents aligned with regulatory authority expectations (e.g., PMDA, FDA, EMA).
Key Responsibilities:
Regulatory Writing & Documentation
- Draft, revise, and QC the following documents:
- Quality Overall Summaries (2.3)
- Module 3.2.S and 3.2.P for biologic and biosimilar products
- CTD summaries for comparability studies, analytical similarity, and protein characterization
- DMF components for biologics (e.g., reference product and biosimilar substances)
(Preferred) Draft or support:
- Module 2.4 (Nonclinical Overview), 2.6 (Nonclinical Summaries)
- Module 2.5 (Clinical Overview), 2.7 (Clinical Summaries)
- Module 5 appendices for biosimilar clinical trials or bridging studies
Collaboration and Coordination:
- Interface with SMEs, CMC experts, QA/QC teams, and regulatory leads across biologics programs.
- Participate in client calls, technical discussions, and submission readiness planning.
Compliance and QC:
- Ensure consistency with ICH CTD format (M4/M8), Q-series guidelines, and country-specific regulations (PMDA, FDA, EMA).
- Conduct internal QC reviews and contribute to template and SOP improvement.
Required Qualifications:
- MSc, MPharm, PhD, or equivalent in Pharmacy, Biotechnology, or Life Sciences.
- Minimum 5- 8 years of experience in regulatory medical writing.
- Direct experience with biologics and/or biosimilars is mandatory.
Strong technical understanding of:
- Biologics CMC documentation (cell line, process validation, comparability)
- Biosimilarity assessments and data presentation
- Familiarity with eCTD publishing standards and document structure.
