Responsible Pharmacist

7 months ago

Johannesburg, South Africa GE Healthcare Full time

**Job Description Summary**: The Regulatory Affairs Manager, South Africa is responsible for the registration of new products and/or marketed products, and for the provision of regulatory guidance in assigned area. The position also includes to be Responsible Person for wholesaler license in South Africa with responsibility for ensuring that a local quality system is implemented and maintained. And to act as Local Safety Responsible and Compliance Officer for GE HealthCare South Africa.

**Responsibilities**:
**Regulatory Affairs Activities**:

- Managing local regulatory activities includes:

- _ Being the contact person for regulatory authority_
- _ Providing advice and support to Regional RA, CRA and Regulatory Operations for registrations and clinical trials_
- _ Creation of local documents and fulfilling local submission requirements_
- _ Creation and keeping regulatory texts (SmPC, package leaflet, labelling, prescribing information) up to date _
- _Responsibility and personal liability for the conformity of the labelling, package insert, SmPC with the content of the Marketing Authorisation_
- _ Compliant and timely data entry in Regulatory Affairs Information (RIM) software (e.g. Veeva)_
- _ Prepare the artwork in Artwork Management System (AMS) according to the SAHPRA labeling requirements ensuring Artwork compliance_
- _ Responsibility for local regulatory archive_
- Provide regular reports to the Regional Associate Director regarding status update of regulatory activities
- Continuous review of national legislation to ensure regulatory compliance for Pharmaceutical Diagnostics products in S.A
- Drive the development and strengthening of relationships within PDx S.A to ensure effective cross functional working and within GRA
- Drive the development and strengthening of PDx relationships with regulatory authorities and act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions.
- To provide Regulatory Intelligence expertise by notifying stakeholders timely about any new regulations in force and share proactively advice on impact to the planned regulatory activities
- Continuous review and putting strategies in place for improvement of existing processes (e.g. revision of local SOPs etc.) and implementing new initiatives to support Commercial
- To assist and ensure compliance in the process of gaining approval of unlicensed products in the country.
- Be responsible of regulatory audits from national Health Authorities
- Complete all trainings assigned timely

**Market Access**:

- Pricing and reimbursement
- Contribute to Negotiations with Authorities
- Ensure appropriate intelligence is in place to follow-up with new regulations, competitors pricing, pricing change for our products
- Be proactive and anticipate the change to support the business
- Promotional Material
- Review and release of S.A advertising material from a RA perspective.
- Manage submission and life cycle of the advertising material (validity & related quality documentation)
- Manage activities associated with benefits to HCP and transparency disclosure, validate contracts and conventions, submit them to HA
- Contribute to Sales Reps training
- Provide proactive regulatory advice and expertise to other groups (Local Commercial, Marketing or Medical Affairs)

**Quality Management / GxP related **Responsibilities**:
Act as Responsible Person for wholesaler license in South Africa with responsibility to:

- Ensure that activities carried out by GE HealthCare, comply with current South African legislation related to Good Manufacturing and Distribution Practices and in accordance with Company policies on Marketing, Storage and Distribution of medicinal products.
- Ensure that a local quality management system is implemented and maintained
- Ensure training of personnel in GE Healthcare in South Africa on those duties assigned to them in relation to GxP Recording of training.
- Co-ordinate and execute recalls in the country. Liaise with national regulatory bodies, as required.
- Ensure that contractors with GDP impact are approved and audited at intervals based on risk assessment and audit reports are stored.
- Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
- Process quality complaints received by the local GE HealthCare organisation and review of quality complaints entered into the TrackWise system by Customer Service to ensure timely co
- ordination of necessary local actions.
- In case of returned, rejected, recalled or falsified products assist central functions in GE HealthCare to obtain a qualified decision of final disposition.
- Approve any returns to saleable stock.
- See to that storage and transport conditions of our products will not compromise the quality and meet the specifications provided by the manufacturer. In the ev

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