Senior Regulatory Affairs Pharmacist

MNA Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Pharmacist to manage product registrations and ensure compliance with health authority regulations across Africa. The role involves overseeing regulatory portfolios, supporting brand teams, and maintaining licenses. The ideal candidate will have a Bachelor of Pharmacy and experience in regulatory affairs.

Qualifications

• Minimum of 2-3 years’ experience in regulatory affairs.
• Knowledge of legislation governing product registration.

Responsibilities

• Manage the regulatory portfolio end-to-end, including product registration.
• Ensure compliance with local, regional, and corporate regulations.
• Support brand teams with regulatory expertise.

Skills

Regulatory Affairs

Pharmacology

Therapeutics

Education

Bachelor of Pharmacy

Medicine Registration courses

Tools

Lotus Notes

Microsoft Office

Docubridge

Job description

A global pharmaceutical company is seeking a Senior 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.

Key Responsibilities:

1. Manage the regulatory portfolio end-to-end, including product registration, labelling, promotional material approval, and compliance with legislation.
2. Support brand teams by providing advice and guidance.
3. Oversee product portfolios in South Africa, English and Portuguese-speaking Africa, and provide regulatory oversight for medicines and devices in Kenya and Ethiopia.
4. Support pipeline and marketed products through submissions, renewals, and approvals, ensuring timely regulatory filings to meet business targets, collaborating with local agents for faster approvals.
5. Maintain existing product marketing authorizations and secure regulatory approval for variations, working with local agents.
6. Stay informed about emerging legislation and guidelines in Kenya and Ethiopia, assessing their impact on the business.
7. Maintain licenses across the African region, including GMP licenses related to the product portfolio.
8. Update regulatory activities in all systems.
9. Review and update package inserts and IFUs in line with CCDS requirements, including MOH submissions, translations, and artwork management.
10. Create, proofread, and approve labelling texts, mock-ups, and artworks in the artwork management system.
11. Immediately notify regulatory requests or safety-related changes, supporting colleagues as needed.
12. Ensure compliance with local, regional, and corporate regulations and provide technical support to the Affiliate Safety Representative and QA.
13. Maintain regulatory trackers for product and country portfolios with monthly updates.
14. Review and approve promotional materials from a regulatory perspective, ensuring compliance with marketing codes and prescribing information.
15. Manage CCDS and label change control databases, providing regular status reports.
16. Support brand teams with regulatory expertise.
17. Coordinate with manufacturing sites, head office, and affiliate departments to ensure regulatory excellence.
18. Participate in product development and project planning, ensuring regulatory requirements are integrated.
19. Support business development efforts in the market.
20. Assist with sales, marketing, complaints, liabilities, and provide medical support and information as needed.
21. Lead advocacy efforts for the product portfolio.
22. Train affiliate staff on regulatory processes.
23. Act as back-up Affiliate Quality Assurance contact and Deputy Responsible Pharmacist as per regulations.
24. Ensure compliance with company policies, statutory, and quality requirements.
25. Responsible for accurate documentation submission to regulatory authorities.
26. Maintain a level of autonomy with project responsibilities, reporting to the Regulatory Affairs Director – South Africa and Region Africa.

Requirements:

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

Applications can be submitted via this portal or through the vacancy link at www.mnarecruitment.com. If no feedback is received within 7 days, consider the application unsuccessful.