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Manager - Regulatory Affairs & Compliance (M/F)

ID:
5284196
Data:
03-04-2018
País:
Angola
Localidade:
Luanda
Categoria(s):
Saúde
Intervalo salarial:
Informação exclusiva JobMatch

Detalhe da Função

Job Purpose:
The main responsibility of this position is to ensure Compliance with all Angolan Ministry of Health and/or other relevant Ministries Regulations pertaining to the Registration, Manufacture, Import, Storage and Distribution of Pharmaceuticals in Angola.

Duties and Responsibilities:
- Responsible for ensuring all OUs (Operating Units) and Products in Angola are Ministry of Health Compliant;
- To ensure within next 2 years 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 Company 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 New Product Development team in the form of approving product packaging art. Leaflets, work/designs/translations and Marketing materials.
- 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;

Education/Experience:
- High Degree in Pharmacy
- 4-6 years of experience in Regulatory affairs in pharmacy market;
- Familiar with WHO Good Distribution & Storage Procedures;
- Detailed knowledge of Ministry of Health regulations & procedures related to Manufacture and commercialization of Pharmaceuticals in Angola/Portugal;
- Knowledge of Portuguese & English is essential;
- Excellent verbal and written communication skills;
- Ability to interpret and implement Regulations and Requirements in a pragmatic manner;
- Ability to ensure compliance with Requirements and Procedures in all OUs in Angola;
- A Good diplomatic Communicator and ability to convince technical issues efficiently;
- Ability to operate with a high levels of integrity, discretion and diplomacy.

We offer:
Attractive salary paid in Portugal, Bonus, Employee benefits (car, accommodation, among others)

To apply for this opportunity, please send your resume, cover letter and salary expectations

Pesquise também por: Manager

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