Associate Specialist, Regulatory Affairs

6 months ago

Midrand, South Africa MSD Full time

**Basic Functions & Responsibility (may not be limited to)**:

- Under supervision of the Country Lead/Senior Director/Director/Associate Director/Manager Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions and renewals and maintenance of local files as well as minor translations and artwork management.
- Under supervision of Country Lead/Director/Associate Director/Manager Regulatory Affairs the incumbent contributes in other regulatory tasks, as required.
- By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.

**Major Activities (may not be limited to)**:

- Administrative office routines
- Assist in department administrative tasks, such as managing invoicing, meeting arrangements, coordinate agendas, take and circulate minutes, travel arrangements, as applicable.

**Editing and labelling**
- Co-ordinate Electronic Medicines Compendium submissions, approvals and record keeping.
- The above-mentioned tasks are performed under supervision of Country Lead/Associate Director/Manager Regulatory Affairs and relevant persons in medical and marketing departments as well as Regulatory Affairs International, Global Labelling, Regulatory Affairs Europe, and MMD.

**Qualification and Experience**:

- ** The incumbent must have a post-secondary education in scientific science or equivalent**.
- The incumbent must demonstrate basic medical and scientific understanding and knowledge. The incumbent should demonstrate basic skills and knowledge of local regulatory procedures.

**Secondary** Language(s) Job Description**:
**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Intern/Co-op (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R284210

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