Open to opportunities

Ashish Baghel

@ashishbaghel

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Regulatory Affairs professional with expertise in formulation development.

United States

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What I'm looking for

I am looking for a role that fosters collaboration, encourages professional growth, and allows me to leverage my regulatory expertise to contribute to innovative pharmaceutical solutions.

I am a dedicated Regulatory Affairs professional with a Master’s in Regulatory Affairs from Northeastern University and over 1.5 years of hands-on experience in formulation development, CMC documentation, and regulatory submissions including IND, ANDA, NDA, and BLA. My academic background, combined with my practical experience, has equipped me with a strong understanding of FDA/ICH guidelines and the intricacies of regulatory compliance.

During my tenure as a Research Scientist at Encube Ethicals, I successfully conducted formulation development for various topical products and authored critical CMC documentation for ANDA submissions. I collaborated effectively with cross-functional teams to ensure successful regulatory filings and maintained rigorous compliance with GMP standards. My ability to align technical and clinical data with regulatory strategy has been pivotal in driving project success and enhancing product quality.

I am passionate about contributing to the pharmaceutical industry by ensuring that products meet regulatory requirements while maintaining high standards of quality and safety. I thrive in collaborative environments and am committed to continuous learning and improvement in the field of regulatory affairs.

Experience

Work history, roles, and key accomplishments

Research Scientist

Encube Ethicals Pvt., Ltd.

Feb 2022 - Present (3 years 4 months)

Conducted hands-on formulation development for topical and semi-solid products, including emulsification, pH adjustment, and scale-up. Authored CMC documentation for ANDA submissions, including process descriptions and formulation rationales, and supported QA review and approval.

ANDA Submissions ICH Stability Studies SOP Development Quality Assurance Risk Assessment

QC Trainee

Symbiotec Pharmalab Pvt., Ltd.

Oct 2018 - Present (6 years 8 months)

Observed documentation practices essential for regulatory compliance, including analytical reports, logbooks, and SOPs aligned with FDA and WHO guidelines. Performed sampling and chemical analysis of raw materials and finished products using validated methods, contributing to batch release readiness.

Regulatory Compliance Quality Control Documentation FDA WHO guidelines Batch

Education

Degrees, certifications, and relevant coursework

Northeastern University

Master of Science (M.S.), Regulatory Affairs

Grade: 3.78/4.00

Activities and societies: Courses: Regulation Strategy for Development, Pharmaceutical & Medical Device Law, Advanced Regulatory Writing New Drug Applications, FDA Pharmaceutical Regulation.

Pursued a Master of Science in Regulatory Affairs, focusing on regulation strategy, pharmaceutical and medical device law, advanced regulatory writing, new drug applications, and FDA pharmaceutical regulation. Achieved a GPA of 3.78/4.00.

Shri G. S. Institute of Technology and Science

Master of Pharmacy, Industrial Pharmacy

Grade: 3.80/4.00

Activities and societies: Courses: Drug Regulatory Affairs, Biopharmaceutics, Quality Assurance Techniques, Pharmaceutical Packaging.

Completed a Master of Pharmacy in Industrial Pharmacy, with coursework in drug regulatory affairs, biopharmaceutics, quality assurance techniques, and pharmaceutical packaging. Maintained a GPA of 3.80/4.00.