PRANJAL JAIN
Delhi
Summary
A Regulatory Affairs professional with around 4.5 years of experience in Biologics (mainly Biosimilars) industry. Employs excellent regulatory submission authoring skills, database management, and multi-tasking skills. Demonstrated ability to comply with the regulatory guidelines. Handled regulatory submissions and compliance starting from the developmental to the post-approval stage in the lifecycle management of the products.
Overview
3
3
years of professional experience
Work History
Executive - Regulatory Affairs
Enzene Biosciences Ltd
Pune
08.2020 - 05.2023
- Responsible for authoring high-quality CMC data for CTA, IMPD, and IND submissions of biosimilars in the EU, US, and Indian markets.
- Responsible for the preparation, compilation, and review of CMC data (Module 2 and Module 3) for the MAA of biosimilars for submissions in the EU, India, and various ROW markets, according to country-specific requirements.
- Involved in the preparation of Scientific Advice and Briefing packages
- Successfully accomplished six biosimilar product launches.
- Establishing a regulatory strategy in line with the requirements of the health authorities, and ensuring timely and high-quality submissions.
- Regulatory evaluation of the change controls, preparation, and timely submission of Query Responses to various Regulatory Authorities and filing of the Post Approval changes/Variations
- Provided guidance and support to the various Stakeholders (CFTs) for the timely readiness of documents for CTA and MAA.
Education
Masters in Technology (M.Tech) - Industrial Biotechnology
National Institute of Karnataka
04-2020
Bachelor's in Technology (B.Tech) - Biotechnology
Banasthali University
04-2018
Skills
- Result Oriented and Organized
- Regulatory Compliance
- Gap Analysis and Strategic Planning
- Right First Time Submissions Quality
- Sharp Reviewing and Authoring Skills
- Adept at Regulatory Strategy
- Quick Implementation
- Reduced Queries
- Precision in Response
- Delivery on Commitments
- Team Building
- Ability to engage effectively with colleagues at all levels
- Attention to Detail
- Strong communication Skills
- Project Management
Internships
- Summer Intern : Sun Pharmaceuticals, Gurugram - June'19 - July'19
- Project Trainee : INMAS, DRDO, Delhi - May'17 - November'17
Accomplishments
- Worked as a single point of contact for all the primary tasks associated with the Regulatory Functions.
- Effectively managed the Clinical Trials (CT) related submissions of Biosimilars.
- Accomplished 6 product launches with minimized queries.
Timeline
Executive - Regulatory Affairs
Enzene Biosciences Ltd
08.2020 - 05.2023
Masters in Technology (M.Tech) - Industrial Biotechnology
National Institute of Karnataka
Bachelor's in Technology (B.Tech) - Biotechnology
Banasthali University
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