Job description for the role:
Responsibilities include preparing CTD/eCTD dossiers, ensuring local (CDSCO) and global (USFDA/EMA) compliance with a focus on CMC (Chemistry, Manufacturing, and Controls) and regulatory intelligence.
- Regulatory Strategy: Develop and implement regulatory strategies for clinical trials, and new drug/marketing authorization applications (MAA).
- Dossier Preparation: Prepare, review, and submit dossiers (CTD/ACTD/eCTD) to various regulatory authorities, including the CDSCO (India) and international agencies.
- CMC & Compliance: Review CMC documentation, including stability protocols, analytical methods, and manufacturing changes for biologics.
- Regulatory Intelligence: Stay current with changing regulatory guidelines, providing updates on impact to company strategy.
- Stakeholder Management: Liaise with R&D, manufacturing, quality, and regulatory agencies to expedite approvals and resolve queries.
Qualifications
- Education: Master's degree in Biochemistry, Microbiology, Biotechnology, or any other Life Sciences
- Experience:10-12 years in regulatory affairs in the biotech industry, specifically in biologics & biosimilars.
- Skills:Proficiency in CDSCO/ DCGI guidelines, Emerging markets guidelines, USFDA/EU guidelines, eCTD submissions. Experience in with local authorities
Key Competencies
- In-depth knowledge of biosimilar regulatory pathways.
- Strong project management and communication skills.
- Ability to work independently and guide team members.
