|Title||REGULATORY MANAGEMENT SPECIALIST|
Ref 6759. A leading multinational Pharmaceutical company has a new and exciting opportunity for a Regulatory Management Specialist to act as the in-country Regulatory Representative in South Africa, as well as providing Regulatory support to other English speaking African companies strategic to the company.
Your responsibilities will include, but not be limited to the following:
Responsibility for the effective management of Regulatory support for LS products and services, e.g. Animal By Products (Antibodies, Recombinant Proteins, Cell Culture Media, etc); In Vitro Diagnostics (Histology IVDs, Blood Typing Reagents, etc); Certified Reference Materials (CRM Portfolio falls under Scheduled substances with specific import requirements); APIs; Pharmaceutical and Food additives.
Ensuring the flawless execution of import and export processes by giving proper support on timely licence/permit applications to the relevant authorities and proper classification of sold portfolio according to the local Regulations and Acts.
Responsibility from advocacy and surveillance activities with local Government authorities and Associations.
Analysing available Regulatory and Compliance information.
Responsibility for completing all trade compliance related licence applications for the company in South Africa as per business needs and commercial activities and tracking updates, renewals and requests through Government channels; reviewing and classifying products against Trade/Regulatory requirements of the South African Government agencies (e.g. SAPHRA, DAFF, DOH, SARS, etc).
Implementing the company’s Regulatory and Trade Compliance Policy, Corporate Regulatory and 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.
Requirements for the role:
Bachelor’s Degree in related fields, such as Faculty of Pharmacy (being registered with the South African Pharmacy Council will be an asset); Biology; Chemistry, etc.
Knowledge of EU and local country animal by product regulations; IVD-Medical Devices, as well as import/export regulations.
A minimum of 3 years relevant industry experience in Regulatory and/or Trade Compliance areas within a Life Sciences company.
Proficiency in MS Office software (Word, Excel, PowerPoint, Project) and ERP systems, while a good knowledge of SAP PRE will be an asset.
Ability to demonstrate good communication and project management skills; strong planning; following up; reporting and analytical skills to achieve accurate and timely results.
Ability to work in multi-cultural teams and open to travel.
If you meet our client’s requirements, please email your CV to email@example.com. If you do not hear from us within 2 weeks, please consider your application unsuccessful.