Cerilliant Corporation Jobs in South Africa : Senior Regulatory Management Specialist
Your Role: A new role has opened up and we are hiring a regulatory management specialist to be based in South Africa. You will be act as the in-country Regulatory Representative and effective management of regulatory support for Merck Life Science (LS) products and services in South Africa and in other strategic African countries that cover the areas of Materials Containing Animal by-Products, and Microbiology, Antibodies, Recombinant Proteins, Cell Culture Media, Medical Devices, IVDs, Electrical Equipment’s, Reference Standards, APIs, Pharmaceutical Excipients, Food Additives Your responsibilities will be to drive, manage and coordinate registration/Notification/Listing activities in South Africa and in other Strategic African Countries that Merck Life Science is commercially active. Ensure the start and completion of registration/notification/listing activities in correct and in timely manner and follow up the change management, final outcome, reporting and maintenance. Build up leadership initiatives for relationship with local authorities and industry associations as per Merck Life Science interest. Be responsible from advocacy and surveillance activities with local governmental authorities and associations. Monitor and report on changes of relevant regulatory and compliance environment with impact to Merck Life Science commercial activities. Analyze available regulatory and compliance information.
You will also insure effective coordination of strategic activities with Merck Subject Matter Experts, Local Regulatory Bodies and Industry Associations. Secure flow of information from/to authorities, industry associations and Merck Life Science organization. And closely work with global/regional regulatory surveillance &advocacy; team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
You will be responsible to complete all trade compliance related license applications for Merck LS in South Africa as per the business needs & Commercial Activities and track the updates, renewals and requests through the government channels, Review and classify products against trade requirements of South Africa government agencies (e.g. drug enforcement agencies, food and drug agencies etc.), Implement Merck`s Trade Compliance Policy, corporate trade compliance standards and best practice procedures and Provide policy direction, advice and guidance for export/import activities to Product Management, Customer Excellence, Field Services, Supply Chain and Distribution.
Who You Are:
- Master level of education in life sciences preferably with a strong emphasis in biology
- Knowledgeable of EU and local country animal by-product regulations, IVD-Medical Device, import/export regulations
- Minimum of 3 to 5 years of relevant industry experience and/or regulatory affairs related to animal by-products, IVDs-MDs, import-export requirements etc.
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems, SAP. Demonstrate good communication & project management skills.
- Ability to work in multi-cultural teams and open to travel
Job Requisition ID: 178952
Location: Gauteng – all
Career Level: D – Professional (4-9 years)
Working time model: full-time
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