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.

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