Everlynne Mainnah Email and Phone Number
Oversee training of teams in GxPs and current Regulatory practises. Licensing- Successfully ensured timely submissions and follow up to approval for Marketing Authorizations, Lifecycle management, including Licence renewals , Label updates and Pharmacovigilance. 17 years’ experience in the Drug regulatory field, with a good network across the Sub Saharan Africa (SSA) Region Sound track record in the registration of various health products and technologies (Human and Veterinary) across the SSA Region GxP consultancy- GMP, GDP, GRP and GPvP, including Audits in these areas. Providing Startegic leadership, Managing both internal and external stakeholdersProviding Reg Intel on latest trends across the SSA region Successfully managed Key projects for various Principals.
Evka Consultz Ltd
View- Website:
- evkaconsultz.com
- Employees:
- 18
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Director Quality Assurance Regulatory AffairsEvka Consultz Ltd 2007 - PresentNairobi• Registration of Pharmaceutical products, Veterinary products, medical devices, herbals, vaccines, radiopharmaceuticals and biologics for Kenya, Uganda, Tanzania, Ethiopia Rwanda and Zambia .• Product Lifecycle management (Product Renewals, Retentions and Variations/ Notifications)• Listing of food supplements, Borderline products• Licensing and Advertisement approvals• Report writing and communication with Principals on Regulatory matters.• QMS setup and implementation. Training of staff on the same in line with GxP regulations.• Submission and follow-up on import/ Export permits at the Pharmacy and Poisons Board.• Follow up on lab analysis of products at the pre-qualified labs.• Oversight of the PV system and all PV activities for the products for which the principal holds a Marketing Authorization. (QPPV)• GxP Audits and Manufacturing site setups• Regulatory intelligence -
Senior Regulatory Affairs Manager SsaAstrazeneca Jan 2023 - Jun 2023Nairobi County, Kenya• Registration Planning and Business support• Implementation of GRP standards in the SSA Hub • Ensuring timely performance of regulatory processes including Marketing authorizations, Lifecycle maintenance, License renewals and Pharmacovigilance activities• Building and maintaining relationships with key internal and External stakeholders to maintain visibility and accessibility.• Local process expert of the Global labelling Business Process.• Training and Development • QPPV Kenya• Strategic Leadership -
Regulatory Affairs SpecialistBd Apr 2022 - Sep 2022Kenya• Securing Marketing Authorization for medical devices for East African Market• Product lifecycle management (Renewals, retentions and variations)• Liaising with the Business units in budgeting for products, preparation of product dossiers.• Updating of reports on shared platforms and sharing the same with Marketing team • Communication of any product quality complaints or reported adverse effects with product use to the Business unit heads and ensuring any Field safety actions are communicated with the Health Authorities. -
Regulatory Affairs ConsultantSanofi Dec 2021 - Mar 2022Kenya- Report writing and communication with principals on regulatory matters.- Securing Market Authorization transfers and product obsoletion in different markets- Product Life cycle management- variations
Everlynne Mainnah Education Details
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Industrial Pharmacy And Regulatory Affairs -
Project Planning And Management
Frequently Asked Questions about Everlynne Mainnah
What company does Everlynne Mainnah work for?
Everlynne Mainnah works for Evka Consultz Ltd
What is Everlynne Mainnah's role at the current company?
Everlynne Mainnah's current role is Regulatory Affairs Director at Evka Consultz Ltd.
What schools did Everlynne Mainnah attend?
Everlynne Mainnah attended Purdue University - The Graduate School, University Of Nairobi.
Who are Everlynne Mainnah's colleagues?
Everlynne Mainnah's colleagues are Brian Omondi, Michelle Mulwa, Eunice Kireru, Rebecca O..
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