Regulatory Compliance Manager

Shalina Healthcare

Shalina Healthcare is recruiting a Regulatory Compliance Manager, to be based in Luanda, Angola.

  • Responsible for ensuring all OUs and Products in Angola are Ministry of Health Compliant
  • To ensure all OUs in Angola are WHO - Good Storage & Distribution Practices Compliant
  • Ensure all Required Conditions and documentation of existing OUs in Angola are in order and valid
  • Ensure all Required Conditions and documentation are complied with for New OUs in Angola
  • Responsible for the Registration of existing and all New Products with the nominated authority in Angola
  • Responsible for Maintaining& manage Sample Storage of each Product and Batch arriving in Angola according to Local Regulatory Authorities requirements & Law
  • Compile all Documents and certificates to create Individual Products Files for all Shalina Product Portfolio and preparing the Future “Product Registration in Angola”
  • Regularly train relevant persons in the requirements of regulatory requirements
  • Keep abreast with all legal statutes and requirements with respect to Healthcare/Pharmaceutical Policy in Angola
  • Interact and maintain good working relations with regulatory authorities
  • Communicate regularly with Regulatory Department of Suppliers/Manufacturers with respect to Angolan Regulations and requirements
  • Assist Product Development team in the form of approving product packaging art. Leaflets, work/designs/translations and Marketing materials
  • In case required interact with independent Testing Laboratories to ensure Product Quality Compliance
  • Develop a comprehensive set of SOPs for the efficient compliance of Requirements and Regulations in Angola
  • Assisting the Marketing Department in Technical related issues and Training
  • Provide information (after consulting with Country Manager) to requests originating from government agencies)
  • Minimum Qualification: B.Pharmacy
  • 4-6 years of experience in Regulatory affairs in that market
  • Familiar with WHO Good Distribution & Storage Procedures
  • Detailed knowledge of Mininstry of Health regulations & procedures related to Manufacture and comercialisation of Pharmaceuticals in Angola
  • Knowledge of Portuguese & English is essential
  • Excellent verbal and written communication skills
  • Ability to ensure compliance with Requirements and Procedures in all OUs in Angola
  • Ability to interpret and implement Regulations and Requirements in a pragmatic manner
  • A Good diplomatic Communicator and ability to convince technical issues efficiently
  • Ability to operate with a high levels of integrity, discretion and diplomacy
  • Only short listed applicants will be contacted
How to Apply
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  • Entidade Shalina Healthcare
  • Local
  • Categoria
  • Tags
  • Publicado 21.09.2017
  • Expira 06.10.2017
  • Partilhar Vaga
  • Reportar erro
  • Traduzir para Português

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