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) o Regulatory strategy reports
- Ensure consistency, scientific accuracy, and regulatory compliance across documents.

2) Quality Control (QC) of Documents
- Perform QC review of straightforward and complex documents including:
- SPC, PI, PIL, RMP o Compiled modules for small molecules and biosimilars o SPL, BE templates, TIF o Aggregate reports, Expert reports
- Ensure documents are delivered with high quality and within agreed timelines.

3) 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.

4) 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.

5) 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:
- Bachelors/Masters/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:
oModule 2 documents o Data analysis for gap assessment o QC of regulatory deliverables
- Excellent written communication, analytical skills, and attention to detail.
- Proficiency in MS Office and docu

📌 Medical Writer (Gurugram)
🏢 Gostravvy
📍 Gurugram