director @ independent consultancy | regulatory affairs drug discovery@ DMS SOLUTIONS LTD
London, Greater London, United Kingdom
Manish Soni (BPharm, MSc, MTOPRA)
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FlashIntel GPTManish Soni (BPharm, MSc, MTOPRA) is a Regulatory Affairs Consultant with 13.4 years of experience in regulatory writing. He has expertise in clinical trials, ICH GCP, variations, Adobe, and marketing authorisations. Currently, he works at Catalent Pharma Solutions in Swindon, Wiltshire, where he specializes in regulatory writing. Manish has extensive knowledge of European, US, and ICH regulations and guidelines, as well as experience in document preparation and compilation for therapeutic areas and pharmaceutical forms. Prior to regulatory affairs, he worked in academic research and pharmaceutical manufacturing facilities.
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I am currently working for Catalent Pharma Solutions based in Swindon, Wiltshire. I am a Regulatory Affairs Consultant with a wide range of experience in regulatory writing. Project experiences include writing and reviewing Module 3, CTD documents (Overviews and Summaries), Post Approval Submissions, GAP Analysis and briefing documents for Regulatory Authorities. I have developed substantial understanding of European, US and ICH regulations and guidelines, with experience in the preparation and compilation of documents for Europe, US, and International, for an extensive product portfolio within a wide range of therapeutic areas and pharmaceutical forms. Prior to entering into regulatory affairs, I worked in academic research and pharmaceutical manufacturing facility. Academic research interests were auto-immune disease and immunotherapy.
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director @ independent consultancy | regulatory affairs drug discovery
Business Consulting and Services
Manish Soni (BPharm, MSc, MTOPRA)'s Professional Milestones
- Global Regulatory Affairs Associate (2012-03-01~2013-05-01): Achieved compliance standards and regulations by efficiently managing international regulatory cases.
- Academic Research Associate (2010-06-01~2010-09-01): Conducted comprehensive academic research to inform strategic decision-making.
Skill
Clinical Trials
Ich Gcp
Variations
Adobe
Marketing Authorisations
Chemistry
Gmp
Ectd
Regulatory Affairs
Labelling/leaflets
Business Objects
Regulatory Requirements
Drug Discovery
Microsoft Office
Pharmaceuticals
Gcp
Drug Development
Clinical Development
Regulatory Submissions
Documentum
Formulation
Pharmaceutical Industry
Glp
Sop
Certification
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Manish Soni (BPharm, MSc, MTOPRA) works for DMS SOLUTIONS LTD
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