Roles and Responsibilities :

- Review of CMC Documents: Evaluate Chemistry, Manufacturing, and Controls (CMC) documentation for US FDA and EMA submissions.
- Drafting eCTD Sections: Prepare and compile electronic Common Technical Document (eCTD) modules in compliance with regulatory requirements.
- Regulatory Document Preparation: Draft regulatory submissions including IND (Investigational New Drug), IMPD (Investigational Medicinal Product Dossier), and briefing books (BB).
- Cross-Functional Communication: Collaborate effectively with internal CFTs to ensure alignment and timely delivery of regulatory documents.
- Regulatory Language Expertise: Ensure clarity, accuracy, and compliance in all regulatory communications and documentation
- Biosimilar Expertise: Apply knowledge of biosimilar guidelines and requirements, including ICH standards, throughout the submission process.
- Technical Proficiency: Manage PDF properties and formatting requirements for eCTD submissions.
- Compliance: Stay updated on global regulatory requirements,



including ICH guidelines for biosimilars.
- Provide strategic guidance on regulatory strategy development for biosimilars products.
- Assist in the preparation and submission of regulatory filings, including RCGM submission, Clinical trial application, recent marketing applications, Post approval changes, renewals, and responses to regulatory queries.

- Stay informed about regulatory requirements and guidelines for biopharmaceutical products in domestic and ROW markets, including CDSCO, ICH, local FDA and other global regulatory agencies.

Job Requirements :

- 2-5 years of experience in Biosimilar/ pharmaceutical industry with expertise in drug regulatory affairs.
- Strong understanding of ActD, ACTD, Biosimilars, CTA, CTD, Dossier preparation & submission processes.
- Experience working in US Market or European Markets (ROW) is desirable.
- Master’s degree in Pharmacy, Life Sciences, or related field

📌 Executive (Pune)
🏢 Enzene
📍 Pune