Justin Evans

Background

About Justin Evans

25 years’ experience within the Pharmaceutical Industry (Reg Ops, Reg CMC and Analytical Chemistry). Established Regulatory Ops Department and Processes for Successful Regulatory Services Company supporting FDA, HC and EU submissions. Strategic, Focused, Detailed and Results Orientated Individual With Positive 'Can Do' Attitude That Strives to Add Value in All Situations. Fast Learner, Bondable/Approachable, Always Willing to Help and Dedicated to the Job Until Completion. Great Attention to Detail, Concern for Excellence, Accomplished Time Management Skills and Good Oral and Written Communication Skills. Computer Literate – Expertise in eCTD Authoring/Viewing Systems (docuBridge, eCTDXPRESS, eCTD Office), e-Validator, MS Office Applications, Adobe Acrobat Professional (and Plug-Ins Such as TRS Toolbox, Pitstop, Aerialist etc). Set Up and Advised Clients How to Set Up ESG And Secure E-mail Accounts With FDA. Worked on a Variety of Dosage Forms such as Metered Dose Inhalers, Capsules, Tablets, IV’s, Drug in Bottle and Radiolabelled Products. Coordinated, Advised, Authored, Published (at the Document and Submission Level) and Submitted eCTD's, NeeS, SPL And Other Submissions on Behalf of Clients. Other Experiences Include: Lead and Coordinated Multi Hierarchical, Global Teams to Author and Deliver the CMC Documents Required As Part of Concurrent Worldwide Regulatory Submissions. Responsibility for Multiple Projects Ranging From Phase I to IV (and Responses to Questions) Ensuring They Were Delivered on Time (and to the Appropriate Quality). Experienced With Most Markets eg, European (MHRA, BfArM etc) As Well As FDA, Health Canada, Japan etc. During the Time I Spent in Analytical Development I Supervised/Organised and Performed Testing/Method Development and Validation. Reported/Communicated and Presented Results to Peers and Management, Wrote SOP's/Guidelines/Reports and Ensured the Correct Operation of the Equipment I Had Responsibility for.