Regulatory Affairs Pharmacist

7 months ago

Johannesburg, South Africa MNA Recruitment Full time

A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.

**Key Responsibilities**:

- Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries.
- Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines.
- Drive registration/variation follow up strategies and find solutions to potential supply challenges.
- Ensure that labelling for Central, East Africa and Mauritius is complaint with in-country specific requirements.
- Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
- Conduct Due diligence activities
- Co-ordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required.
- Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines.
- Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions).
- Respond to product-specific queries from Central, East Africa and Mauritius countries where required.
- Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
- Download information from external portal i.e. Docubridge, sharepoint, we-transfer or regulatory drive.
- Arrange for translations of overseas documentation if required.
- Schedule Microsoft team meetings or teleconferences as needed.
- Conduct training sessions with Central, East Africa and Mauritius Team to ensure quality submissions in line with guidelines and upskilling of team members.
- Standardize folder structures and save information on NRD - Central, East Africa and Mauritius folder.
- Liaise with principals or the company with regards to outstanding information.
- Verify documents for completeness and current information.
- Compile and maintain spreadsheets and status reports as needed and upon request.
- Compilation of work map trackers to ensure visibility of tasks.
- Ensure Central, East Africa and Mauritius registrations are renewed in a timeous manner and retention fees are paid as required.
- Assist with task risk management and compilation of risk plans when associated with submissions.
- Ensure the completion of all assigned Company training within the specified timelines.
- Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs

**Requirements**:

- Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
- 3-5 years’ experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
- Should have a sound knowledge of Sub-Saharan countries regulatory requirements and guidelines.
- Must have experience and understanding of electronic document management systems / eCTD.
- High level Computer literacy.
- People skills - highly adapted interpersonal skills.
- Problem solving analysis skills.
- Priority setting - initiative and follow through.
- Time management and ability to self-motivate.
- Strong attention to detail.
- Ability to work under pressure.
- Embodies Values & Behaviours in all internal and external interactions

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