Regulatory Affairs Manager

2 weeks ago

Midrand, South Africa Cipla Full time

**Division**:
Regulatory Affairs

**Department**:
Regulatory Affairs

**Employment Type**:
Permanent

**Job Purpose**:

- Manages submissions to different Health Authorities within the Regulatory Affairs function by ensuring the targets are reached as committed during each financial year.
- Manages registrations and engagement with the different Health Authorities to ensure targets are met w.r.t. registrations and launches.
- Manages every aspect of product Life-Cycle management within the Regulatory Affairs function by ensuring that the dossiers submitted and registered are up to date with any changes or variations in order to ensure dossier compliance and maintenance and minimize risk. Ensures that administration related to the Management of these processes are conducted according to departmental procedures for all products.
- Leads a group of RA Pharmacists/Scientists directly in all aspects related to objectives and delivery thereof.
- Provides RA Intelligence to RA Executive and RA Director on all projects and processes related to key objectives

**Accountabilities**:

- **Provides regulatory Intelligence to Cipla RA Managers/Executives/ RA Director and CEO. Provides insight into impact to business and strategies to adapt.**
- **Ensures pre-launch stage product submission and registration activities**
- **Ensures dossier life cycle management registration activities by ensuring the following activities are conducted**
- **New Business Development Implementation**
- **Supports and enables delivery of Regulatory Affairs Pharmacists/Scientists**
- **Develops and manages stakeholder relationships**
- **Lead and develop the regulatory affairs team**

**Education Qualification**:
B Pharm degree or higher (post graduate)

**Relevant Work Experience**:
Min. 5-10 years’ experience in regulatory affairs covering all areas of the function. At least 2-3 years’ experience in managing others. Proven skills in**Business acumen, People Management experience, Negotiation and influencing skills and a collaborative approach.

**Employment Equity**:
Cipla is an Employment Equity employer, and this position will be filled based on our Employment Equity Plan.

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