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Regulatory Management Specialist

Your Role:
A new role has been opened up and we are hiring a regulatory management specialist to be based in South Africa/Johannesburg.

You will act as the in-country Regulatory Representative in South Africa and will also give the regulatory support to other English-Speaking African Countries strategic for Merck Life Science (LS). You will be responsible from the effective management of regulatory support for LS products and services such as  Animal by Products (Antibodies, Recombinant proteins, Cell Culture Media etc.), In-Vitro Diagnostics (Hematology, Histology IVDs, Blood Typing Reagents etc.), Certified Reference Materials (CRM portfolio fall under scheduled substances with specific import requirements), APIs, Pharmaceuticals and Food additives.

Your responsibilities will be to drive, manage and coordinate Registration/Notification/Listing activities in South Africa and in other Strategic English Speaking African Countries that Merck LS is commercially active. Ensure the flawless execution of import and export processes by giving  proper support on timely license/permit  applications to relevant authorities and proper classification of sold portfolio according to the local regulations and acts.
Build up leadership initiatives for relationship with local authorities and industry associations as per Merck LS 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 Global Merck Subject Matter Experts (SMEs), 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 SMEs 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/Regulatory requirements of South Africa government agencies (e.g. SAPHRA, DAFF, DOH, SARS etc.), Implement Merck`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.

 

Who You Are:
• 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.

• Knowledgeable of EU and local country animal by-product regulations, IVD-Medical Device, import/export regulations
• Minimum of 3 years of relevant industry experience in Regulatory and/or Trade Compliance area within a Life Science Company.

• Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems.(Good Knowledge on SAP PRE will be an asset)

• Demonstrate good communication & project management skills. Strong planning, follow up, reporting and analytical skills to achieve accurate and timely results,
• Ability to work in multi-cultural teams and open to travel

Job Requisition ID:  197265
Location:  Gauteng - all
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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