Regulatory Affairs Officer

4 weeks ago

Johannesburg, South Africa B. Braun Medical (Pty) Ltd. Full time

B. Braun Medical Pty Ltd based in Johannesburg, South Africa require the services of a Regulatory Affairs Officer to be based at our Head Office in Northriding, Johannesburg.

B. Braun is a leading medical device and pharmaceutical company, which currently has more than 63,000 employees globally, and offices and production facilities in more than 60 countries. Its headquarters are located in Melsungen, Germany.

**Duties and responsibilities**:

- Assist Regulatory Pharmacists with creating, updating, submissions and maintenance of product registration document (dossier) in accordance with the applicable regulations.
- Conduct administrative tasks within the regulatory department and maintain database of regulatory information.
- Ensure that all departmental administrative duties are carried out accurately and diligently.
- Ensure all dossiers are appropriately audited and superseded as per timelines.
- Maintain all trackers in the RA department.
- Maintain Safety Data Sheets.
- Request payments for RA department as per B. Braun processes.
- Maintain RA Department employees Job Files.
- Assist in the compilation and submission of dossiers to Regulatory Authorities.
- Assist in compilation and co-ordination of submission of variations for currently marketed products.
- Coordinating responses to the regulatory authority committee recommendations (clinical, P&A, naming and scheduling and inspectorate) timeously, in accordance with guidelines and under the supervision of the Pharmacist.
- Assist Regulatory Pharmacist with the coordination of responses to Global Regulatory Affairs (GRA) department queries timeously, to satisfy the requirements of the business.
- Ensure that the master dossiers and copies thereof, are stored, maintained, and controlled in accordance with the relevant SOP.
- Ensuring that the agreed timelines are continuously being met.
- Updating of PI and PIL leaflets to follow latest SAHPRA guidelines.
- Compile RA section of PQR’s.

**Professional competencies**:

- At least 2-3 years pharmaceutical experience with specific focus areas in RA Affairs.
- BSc Degree or equivalent with science background will be an advantage.
- Computer literate with basic Microsoft (incl excel) experience.
- Basic administrative skills.
- Keep abreast with all guidelines, regulations and legislations.
- Knowledge of the Regulatory requirements for medical products of all countries with which B. Braun ZA affiliates with.

**Personal competencies**:

- Results and performance driven - deliver results that meet or exceed expectations.
- Takes initiative and accountability.
- Integrity.
- Highly motivated.
- Intellectual curiosity - willing to suggest and try new ideas.
- Positive and pro-active approach to business tasks.
- Excellent interpersonal and communication skills.
- Positive ‘can - do’ attitude.
- Honest and trustworthy.
- Respectful and highly personable.

**What we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Closing date**:

- 27.11.2023

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