Our Client, a world-leading healthcare company, has a global presence in more than 150 countries, owning production plants in more than 35 countries. Following their expansion in Angola, this multinational company is looking for:
Regulatory Affairs Specialist (Portuguese speaker) – ANGOLA
This role is to be based initially based in Portugal or South Africa, although candidates must be willing to relocate to Angola. This person will be reporting to the Southern Africa Head of Regulatory and it will assume the Evaluation, Compilation and Submission of Registration Application dossiers to Portuguese speaking Authorities in Africa in accordance with local regulatory requirements. With the skill to lobby and network with Regulatory Authorities and External network groups/ industry partners, this professional must work well under pressure and still maintain sound decision making ability. Self driven, good negotiation skills and attention to details are other key factors for the success in this position.
The Regulatory Affairs Specialist responsibilities include:
- To, submit registration dossiers to support full product lifecycle activities in accordance with the country specific requirements to relevant Portuguese speaking Regulatory Authorities in Southern Africa;
- Validation of the accuracy of the translated submission documents including Dossier Maintenance, prescribing information artwork etc;
- Review of promotional material in accordance with the Company’s Promotional and Marketing Code to assure Regulatory compliance;
- To maintain the relevant Global, local Regulatory and compliance databases;
- To monitor, asses and provide input to changes in local regulatory environment;
- To be the company’s representative with the Regulatory Authority in the respective countries. To align regulatory product registration submission strategy to commercial product strategy;
- Market Launch Coordinator for Portuguese language artwork changes and development;
- Manage the Manufacturing Site Registration / Licensing of products in Angola;
- Follow-up with the regulatory authority on all submissions and resolutions in a timely manner in line with critical business priorities;
- Ensure compliance and maintenance of all approved products.
Requirements:
- Bachelor of Science Degree or equivalent;
- Angolan citizenship will be a plus;
- 2 to 5 years experience in a pharmaceutical regulatory environment ideally in emerging markets;
- Experience of working with Southern Africa markets will be an advantage;
- Technical ability to validate translated submission documentation ,labeling packaging text and promotional materials will be valued;
- Experience of interacting with Regulatory Authorities and providing input to emerging legislation;
- Portuguese and English language fluency skills;
- Availability to be initially based in Portugal or South Africa and then relocate to Angola.