Experience

Medicom Healthcare

• India
• Hospitals and Health Care
• 1 - 100 Employee

• Head Of R&D and Global Regulatory Affairs

  • Oct 2018 - Present

  ● Responsible for ophthalmic product (Medical devices and Pharmaceutical) development from product design to commercialization. This include working with contract research laboratories and several contract manufacturing organizations in Europe and India for product development, validation, registration and commercialization. ● Responsible for medicinal products and medical devices regulatory related activities (licenses maintenance, RTQ’s, regulatory strategy, due diligence for new assets, Medicinal product dossier and medical devices technical file authoring, reviewing, Technical file and dossier conformance activities, e-CTD publishing, regulatory audits/ inspections, package submission, liaising with regulatory authorities and Notified bodies for Medical devices ● Responsible for departmental staff training, procedure update and improvements activities.



PRONATURE LIMITED

• United Kingdom
• Business Consulting and Services

• Managing Director

  • Dec 2013 - Present

• Product Development Manager

  • Jul 2016 - Oct 2016

  • Developed regulatory application packages including templates, step by step instructions to securing product marketing approval from regulatory authority in Nigeria



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Project Manager CMC

  • Jun 2017 - Dec 2017

  • Responsible for validation work stream of multi- stage process technology transfer project involves multiple sites across various countries for sterile biopharma product. • Responsible for validation work stream of multi- stage process technology transfer project involves multiple sites across various countries for sterile biopharma product.



Genpact Pharmalink (AMGEN Project)

• Senior Regulatory Affairs Consultant

  • Oct 2016 - Jun 2017

  ● Responsible for CMC lifecycle project for various biopharmaceutical (Large molecules) products, ranging from dossier preparation, maintenance, regulatory compliance activities, dossier authoring and/or redaction of core quality modules as appropriate for European and Rest of the world submissions including: Clinical trial and MAAs, License renewals, variations etc ● Provided regulatory intelligence and registration requirements to support CMC and biosimilars strategy across the product lifecycle and across all Client regions and territories as requested



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Regulatory Specialist - Freelance

  • Jun 2014 - Jun 2016

  • Prepared, reviewed and/or approved regulatory dossiers for global regulatory submission, site transfers, and fulfilment of post approval commitments for my allocated product portfolio• Managed, coordinated, and reviewed product licences for GSK and third party clients• Managed transfer and new product introduction for dermatology, inhalation and sterile products• Assess regulatory implications for site and third party customer change requests and provide advice to ensure continued compliance for batch release against registered details• Managed deviations, release specification, manufacturing guide, TTS, and SOP updates• Performed gap analysis on manufacturing and product registration processes and procedures, managed gap remediation activities including CAPA actions

• Quality Project Lead - Sterile API Manufacturing - Freelance Consultant

  • Oct 2013 - May 2014

  • Worked on a third-party manufacturing projects, reporting to site quality director• Managed technical transfer of analytical method and last phase of process validation • Oversaw validation of bespoke equipment and the validation of analytical method• Reviewed documents and performed gap analysis against standard and written procedures• Ensured that production activities were performed in line with the customer requirement• Supported the site audit preparation with compliance activities for GMP and pre-approval audits.

• Manufacturing & Quality Development Officer

  • Apr 2010 - Sep 2013

  • Acted as a site regulatory compliance specialist for a number of API’s• Compiled and reviewed various sections of drug substance e-CTD for new application and existing product line extensions• Performed gap analysis/ risk evaluation on analytical procedures and techniques, analytical works for batch release, regulatory compliance and improvements • Managed analytical test reduction project and acted as a point of contact for technology transfer• Led the evaluation and introduction of new technology (UPLC) and subsequent method development and validation activities on site



AstraZeneca, Cheshire, UK

• Early Drug Evaluation Scientist

  • Jun 2009 - Apr 2010

  • Reviewed and compiled early CTD for regulatory submission • Provided analytical support for early process development, process validation, technical transfer and product life-cycle management to aid drug candidate selection. • Developed & validated analytical test method & specifications for early stage drug products • Developed early drug formulations for pre-clinical and phase one clinical trial. • Reviewed and compiled early CTD for regulatory submission • Provided analytical support for early process development, process validation, technical transfer and product life-cycle management to aid drug candidate selection. • Developed & validated analytical test method & specifications for early stage drug products • Developed early drug formulations for pre-clinical and phase one clinical trial.



Reckitt Benckiser

• Italy
• Chemical Manufacturing

• Analytical Chemist

  • Jan 2008 - Feb 2009

  • Provided analytical support for early process development, process validation, product technical transfer and product life-cycle management • Performed product analysis, stability testing, method development and method validation • Conducted activity risk assessment, feasibility studies, and investigation for projects • Provided analytical support for early process development, process validation, product technical transfer and product life-cycle management • Performed product analysis, stability testing, method development and method validation • Conducted activity risk assessment, feasibility studies, and investigation for projects