Regulatory Affairs Pharmacist

MNA Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 30 000 - 70 000; Full time

Job summary

A global pharmaceutical company is seeking a Regulatory Pharmacist to ensure compliance with health authorities across Africa. This role involves managing regulatory processes for product registration, maintaining licenses, and providing technical support to various teams. The ideal candidate will have a Bachelor of Pharmacy degree and experience in regulatory affairs. This position offers an exciting opportunity to influence product development and regulatory excellence in a dynamic industry, while contributing to the health and safety of communities across the region.

Qualifications

• Bachelor of Pharmacy degree or equivalent is required.
• 2-3 years’ experience in regulatory affairs is essential.

Responsibilities

• Manage end-to-end regulatory processes for product registration and compliance.
• Support brand teams with regulatory expertise and guidance.

Skills

Regulatory Affairs

Product Registration

Compliance

Pharmacology

GMP Knowledge

Technical Support

Education

Bachelor of Pharmacy

Courses in Medicine Registration

Tools

Lotus Notes

Microsoft Office

Docubridge

Job description

A global pharmaceutical company is seeking a Regulatory Pharmacist responsible for ensuring that new products are registered and existing registrations are maintained according to the current requirements of various Health Authorities in Africa.

Responsibilities include:

1. Managing the end-to-end regulatory processes for the portfolio, including product registration, labelling, promotional material approval, and compliance with legislation.
2. Supporting the brand team with advice and guidance.
3. Overseeing the product portfolio in South Africa and English Portuguese Africa, with regulatory oversight of medicines and devices in Kenya and Ethiopia.
4. Supporting pipeline and marketed products through submissions, renewals, and approvals, ensuring timely regulatory filings and working with agents to expedite approvals.
5. Maintaining existing product marketing authorizations and obtaining regulatory approval for variations, collaborating with agents for faster approvals.
6. Staying updated on emerging legislation and guidelines in Kenya and Ethiopia, assessing their potential impact on the business.
7. Maintaining licenses in the African region, including GMP licenses related to the product portfolio.
8. Updating regulatory activities in all systems.
9. Reviewing and updating package inserts, ensuring compliance with CCDS requirements and IFU, including MOH submissions, translations, and change control in artwork management systems.
10. Creating, proof-reading, and approving country-specific labelling texts, mock-ups, and artworks.
11. Immediate notification of regulatory requests, safety labelling changes, safety restrictions, and external inspections, supporting regulatory colleagues as needed.
12. Ensuring compliance with statutory local, regional, and corporate regulations.
13. Providing technical support to Affiliate Safety Representatives and QA.
14. Maintaining regulatory trackers for products and country portfolios.
15. Reviewing and approving promotional material from a regulatory perspective, in line with marketing codes and registered prescribing information.
16. Managing CCDS and label change control databases, providing monthly status reports.
17. Supporting brand teams with regulatory expertise.
18. Collaborating with manufacturing sites, head office, and other departments to ensure regulatory excellence.
19. Participating in product development, project planning, and future organization initiatives.
20. Supporting business development efforts.
21. Providing support for sales, marketing, product complaints, and liabilities, including medical support and information.
22. Leading advocacy efforts for the product portfolio.
23. Training affiliate staff on regulatory processes.
24. Acting as Affiliate Quality Assurance backup, fulfilling regulatory and quality assurance requirements, and deputizing as Responsible Pharmacist as needed.
25. Ensuring documentation accuracy for submissions to regulatory authorities.
26. Maintaining a degree of autonomy and project responsibility under supervision.
27. Accountable to the Regulatory Affairs Director – South Africa and Region Africa.

Requirements include:

• Bachelor of Pharmacy degree or equivalent.
• Additional courses in Medicine Registration, Advertising Medicines, or related fields are advantageous.
• Proficiency in Lotus Notes, Microsoft Office, and Docubridge.
• Management qualification is a plus.
• Knowledge of current legislation on product registration, advertising, and GMP.
• Understanding of pharmacology and therapeutics.
• Minimum of 2-3 years’ experience in regulatory affairs.
• Experience with pharmaceutical marketing is desirable.

Interested candidates may submit applications via this portal or through the vacancy link on www.mnarecruitment.com. If no feedback is received within 7 days, consider your application unsuccessful.