Regulatory Affairs Pharmacist

6 days ago

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

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

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**:

- Monitor and follow up on the progress of submissions.
- Activities relating to product lifecycle management.
- Maintain and develop working relationships effectively and provide required regulatory support.
- Reviewing artwork relating to products ensuring that it is in compliance with all legal requirements.
- Checking Format and Content Compliance with latest codes of conduct and regulations.
- Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.

**Professional competencies**:

- Bachelor of Pharmacy degree is essential.
- Registration with the South African Pharmacy Council (SAPC) is essential.
- Minimum of 2-4 years Regulatory Affairs experience in pharmaceutical industry.
- Experience working with SAHPRA and other Regulatory Authorities in Africa.
- Experience submitting eCTD - good computer literacy skills also required.
- Knowledge of Acts, Regulations and guidelines pertaining to the Pharmaceutical Industry.
- In-depth knowledge of regulatory requirements.
- Understanding of regulatory compliance and the impact this can have on the business.
- Good Understanding of Quality Management Systems, SAHPRA Guidelines and Policies, Medicines and Related substances and regulations, GMP and any other QA/RA related guidelines.

**Personal competencies**:

- Excellent spoken and written English.
- Strong communication skills - experience in liaising with Business Managers, Quality Assurance & Marketing departments.

**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**:

- 12.02.2024

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