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USD 150 /hr

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Hire Dr. Dilip B.

United Kingdom

USD 150 /hr

Endorsed by the Royal Academy of Engineering as having exceptional Talent in Biomedical and Medical sciences

Profile Summary

I am the holder of highly prestigious Tier 1 Exceptional Talent Visa and endorsed as such by the Royal Academy of Engineering in the fields of e-cigarettes; Biomedical and Medical sciences; and Innovation and Policy. I am an experienced researcher and specialist in the Regulatory Compliance and Quality Management Systems (QMS). I am a curious individual with the ability to adapt, be agile, self-learn, and draw on the experiences of those around me. I have extensive experience in developing, implementing, and managing production processes and QMS for inhalation products in compliance with the TPD2 Directive, cGMP, and ISO 9001. Further, I have an immaculate track record in regulatory compliance to TPD2, CLP, REACH, and CDG regulations. I have an in-depth understanding of the Medical Device Regulations (MDR) and have experience of preparing and submitting Technical Files for a Class 1 Medical Device to Germany’s BfArM. I hold a PhD in Neuroscience and BSc (Hons) in Molecular and Cellular Biology from the University of Central Lancashire. My PhD was partly funded by the ORSAS scholarship.

Subject Matter Expertise

• ★ Pharmaceutical Regulatory Affairs
• ★ European Medical Device Regulation (MDR)
• ★ Regulatory Affairs
• ☆ Analytical Chemistry
• ☆ PCR
• ☆ Blotting
• ☆ Extractable & Leachable Testing
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Survey Design & Methodology
• ☆ Regulatory Writing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting, Newswriting

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Big Data Analytics, Data Processing

Product Development Formulation, Product Evaluation, Product Validation, Manufacturing

Work Experience

Regulatory Systems Associate

Reckitt Benckiser Plc

November 2020 - Present

Principal Consultant

ENDS Consultancy Ltd.

June 2018 - Present

Chief Science and Compliance Officer

An e-liquid manufacturer

February 2016 - May 2018

Senior Operations Officer

An e-liquid Manufacturer

December 2014 - February 2016

Laboratory Demonstrator

University of Central Lancashire

August 2011 - August 2014

Education

PhD, Neuroscience

University of Central Lancashire

October 2010 - January 2015

BSc (Hons.) Molecular and Cellular Biology

University of Central Lancashire

September 2007 - June 2010

Certifications

• SPSS Statistical Training

  University of Central Lancashire

  December 2020 - Present

• Certificate in Graduate Research Skills

  University of Central Lancashire

  October 2010 - Present

Publications

PATENT

(2019). Apparatus and methods for collecting emissions from a device .

DISSERTATION THESIS

Bhuva, Dilip (2015) Dynamins and myosin-II regulate the distinct modes of synaptic vesicle exocytosis in mature cerebrocortical nerve terminals and this involves calcium dependent phosphorylations. Doctoral thesis, University of Central Lancashire .

CONFERENCE POSTER

Ashton, A.C., Bhuva, D.A., Singh, D.S. and Sihra, T.S. (2013). The role of dynamin and myosin 2 in regulating the mode of synaptic vesicle exocytosis. Annual society of Neuroscience Conference. 424.14/G51 .

Ashton, A.C., Patel, M.H., Bhuva, D.A. and Sihra T.S. (2011). Regulation of modes of synaptic vesicle release in control and diabetic nerve terminals. Annual Society of Neuroscience Conference. 445.17/D42 .