Uchenna Ezeh-Adesugba

Experience

• 

  NAFDAC Nigeria

  Oct 2005 - Sept 2006

  Regulatory Officer

  National Agency for Food and Drug Administration and Control (NAFDAC) (Lagos, Nigeria)Advise clients on the requirements for the registration of food, drugs, water and cosmetics, both locally manufactured and imported.Routine inspection of food, water, cosmetics and Pharmaceutical industries to ensure quality standards and Good Manufacturing Practices (GMP) are in placeVet samples of finished drug products to ensure that they meet required standards.Attend monthly approval meetings of food, drugs, water and cosmetics approval and registrationInspection of storage facilities for controlled substances and chemicalsPrepare import and clearing permits for importers of controlled substances and chemicalsPrepare weekly and monthly reportsAnalyse drugs in the laboratory. Show less

• 

  Ecomed Pharma Nigeria Limited

  Aug 2007 - Oct 2007

  Medical Representative

  Medical detailing of Ecomed productsHolding meetings with health care providers and professionals to increase awareness of Ecomed productsSales and marketing of Ecomed products.

• 

  Swiss Pharma Nigeria Limited

  Oct 2007 - Oct 2009

  · Registration of company pharmacists' and premises with Pharmacists’ Council of Nigeria· Registration of New products, license renewal and submission of variations· Obtain NAFDAC's approval for adverts· Artwork and Promotional materials vetting and approval· Monitor and keep in touch with changes in the regulatory environments Sample and analyse raw, packaging, promotional materials and finished products to ensure that they meet standard specifications.Approve and release the above mentioned for use if they are found to be satisfactoryPerform in-process checks to ensure that quality is being built into the products being manufactured.Calibrate all weighing balances being used in the factory weeklyEnsure that documentation is carried out properly to ensure proper recording and traceability.

  • Regulatory Affairs Officer

    Mar 2008 - Oct 2009

  • Quality Assurance Officer

    Oct 2007 - Mar 2008
• 

  GlaxoSmithKline

  Oct 2009 - Mar 2012

  Regulatory Affairs Executive

  • Regulatory Affairs Executive responsible for drugs, vaccines, food and cosmetic products• Registration and maintenance of licenses with the relevant regulatory Agencies• Registration of promotional materials• Consistent maintenance of compliance and update of the required databases• Submission of Clinical trial application and following up for approval• Quality Management System (QMS) champion for the Nigerian market responsible for self-inspections of the different functions and maintaining audit readiness• Check and release of imported products• Named safety contact (NSC) back up for the company assisting the NSC with reporting adverse events as well as providing adverse events trainings to colleagues and new joiners• Provide support during Health Authority inspection of the manufacturing site, warehouses or the offices Show less

• 

  PZ Cussons

  Mar 2012 - May 2013

  Regulatory Affairs Manager

  · Regulatory Affairs Manager responsible for drugs, cosmetics and food products.· Registration and maintenance of licenses with the relevant regulatory Agencies· Ensure factories are cGMP compliant by monitoring, guiding, and conducting self-inspection audits· Process export permits to facilitate export business· Communicate new developments or variations effectively with the marketing team· Registration of advertisements with NAFDAC and APCON· Obtain permits for controlled substances (Import & clear)· Obtain Clearance Permits for products to facilitate import· Represent PZ in relevant trade associations - imports (NIROPHARM) and local manufacture (PMGMAN) Show less

• 

  Pfizer

  Jun 2013 - Feb 2014

  Regulatory Affairs Manager

  • Registration and maintenance of licenses with the relevant regulatory agencies• Monitor regulatory intelligence and communicate new developments or changes to policy and regulations that may affect the business to all relevant stakeholders• Maintain compliance and ensure that all regulatory databases are up to date• Represent Pfizer in relevant trade association meetings like NIROPHARM, Anti-counterfeiting collaboration• Vet and approve promotional materials and ensure registration of advertisement materials with the relevant regulatory agencies before use Show less

• 

  JTI (Japan Tobacco International)

  Mar 2014 - Dec 2016

  Corporate Affairs & Communications Manager, West Africa

  • Ensure all internal and external messaging is consistent with agreed company standards and goals• Develop political, regulatory, and media engagement strategies to ensure that the company's position and views are presented in a fair and accurate manner to adequate stakeholders• Establish clear performance criteria and objectives for all Public Relations consultants and/or agencies engaged by the company in the region• Analyze communications effectiveness, monitor the performance, assess results against goals and apply the insights to optimize spend, design and content delivery• Identify Corporate social Responsibility projects and Corporate Philanthropy initiative in market and follow up on JTI's engagement Show less

• 

  Novartis

  Aug 2019 - now

  • RA Policy Lead for the SSA Region which is made up of 4 Clusters (English West Africa - EWA, East Africa - EAC, French West & Central Africa – FWCA and Southern Africa - SAC) and 46 countries.• Responsible for regulatory oversight of clinical trials in SSA Region• Successful and continuous harmonization and streamlining of RA operations across Novartis Innovative Medicines (IM), Sandoz (generics) and Access portfolios within SSA• Successful Africa Vaccine Regulatory Forum (AVAREF) scientific advice for Novartis malaria platform trial• Regulatory strategy development for all key assets within the Region (Innovative medicines, generics and biosimilars)• Development of policy road map for all four Clusters in SSA which led to identification of our key policy focus areas, stakeholders and actions to shape our regulatory environment• Successful biosimilar workshop for regulators in FWCA Cluster with speakers from Novartis and Health Canada in 2021. Another workshop planned for 2022• Represent Novartis in the trade association meetings (IFPMA) and on sub-committees discussing key topics like e-labeling, African Medicines Agency (AMA) and Africa Medicines Regulatory Harmonization (AMRH) initiatives, clinical research in LMICs, e-CPP, Sampling and Reliance• Led an exercise between Novartis and the European and Developing Countries Clinical Trials Partnership (EDCTP) to evaluate the clinical trial regulatory landscape in SSA, identify gaps and propose solutions. Output of this engagement supports capacity building activities within the Region• Providing oversight for all Safety label changes in SSA leading to improvement of safety metrics across the Region Show less • New Product registration and life cycle maintenance activities in English West Africa• Submission strategy development and implementation for product registration, license maintenance and clinical trials within the Cluster• Improve compliance and ensure KPIs are met consistently• RA Lead in Health Authority interactions such as pre-submission meetings, inspections, other meetings with regulators within the Cluster.• Preparation for product launches including review and registration of promotional materials.• Represent Novartis in the Industry Associations like Africa Regulatory Network (ARN) of IFPMA, NIROPHARM (Nigeria) and AREPI (Ghana) and help shape the regulatory environment.• Provide regulatory intelligence and advice the cross-functional team on any changes in policy or regulations that may impact the business• Lead and manage RA Team in the Cluster supporting their development to build a high performing team• Drive Anti-counterfeiting strategy agreed for EWA Cluster Show less • Regulatory Lead on Global project team for an established oncology product• Successful submission of combined Type 2 variation to update the SmPC with the outcome of the clinical measures of the Paediatric Investigation Plan (PIP) for this product and compliance check of the last clinical measure of the PIP.• Successful collaboration with cross functional team to update SmPC as a result of 2 safety signals (internal and external) and submissions to EMA• Successful preparation, review, and submission of post-approval global regulatory submissions as required, including but not limited to; variations, PSURs, RMP, safety changes and Investigator's Brochure (IB)• Coordinate preparation and review of responses to Health Authority questions• Support RA Country colleagues where product is registered with responses to health authority questions• Co-ordinate preparation of regulatory documentation to support ongoing clinical trials, including Paediatric Investigation Plans• Prepare and dispatch CSRs for completed trials within set timelines compliant with local procedures as well as HA requirements• Update required databases such as DRAGON, Health Authority Request Tracker (HART), Paediatric tracker Show less

  • Head, Regulatory Affairs Policy & Strategic Operations SSA

    Nov 2020 - now

  • Head, Regulatory Affairs, English West Africa Cluster

    Dec 2016 - Nov 2020

  • EU Global Program Regulatory Manager (Ad-interim)

    Aug 2019 - Jun 2020