Shalina Healthcare is recruiting a Regulatory Compliance Manager, to be based in Luanda, Angola.
Duties
- 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)
Requisites
- 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
Notes
- Only short listed applicants will be contacted
How to Apply