Itunu Ajayi
Regulatory Affairs Manager at HealthLine Limited- Claim this Profile
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Bio
Experience
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HealthLine Limited
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Nigeria
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Manager
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Jan 2013 - Present
- Registration and Regulation of Pharmaceutical Products, Cosmetics,Medical Device,Food, Chemicals - Maintaining data and files for future reference, particularly in the event of an audit by a Regulatory Agency - Acting as a liaison between my organization and Regulatory Agency (NAFDAC) on Registration and Regulatory matters - Maintaining a deep understanding of new and existing regulations that may impact my organization’s products and processes -Using that understanding to standardize all business operations and establish clear, documented protocols. - CTD dossier assessor - GMP inspection applications - letter of no objection applications - E-Licence applications - Variation applications - Cold Chain inspection applications - Clinical trials product registration expert - Pharmacovigilance applications - WHO product Registrations - Drug Registrations - Cosmetic products registrations - Medical devices registrations - Food registraions - Herbal product registrations - Mobile Autentication Stickers applications - Advert applications - Expert with NAPAMS operation/applications Show less
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Alkem Laboratories Ltd.
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Officer
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Apr 2009 - Nov 2012
A goal driven registration and regulatory officer Ensure that products are registered before party shipped into the country Stamping of shipping documents with the Regulatory Agency to ensure issuance of release stamp A goal driven registration and regulatory officer Ensure that products are registered before party shipped into the country Stamping of shipping documents with the Regulatory Agency to ensure issuance of release stamp
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Education
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University Of Ado-Ekiti
Bsc, Business-Administration -
Pharma Drug Regulatory Affairs Course Certificate