Senior Regulatory Affairs Specialist - Pharma | Bloemfontein

Placements24

Bloemfontein

On-site

ZAR 900,000 - 1,200,000

Full time

3 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Health insurance

Retirement fund

Performance-based bonuses

Training programs

Career development opportunities

Job summary

Placements24 in Bloemfontein, Free State, seeks an experienced Senior Regulatory Affairs Specialist to ensure compliance with SAHPRA and international regulations for development, registration and lifecycle management of pharmaceutical products. You will shape regulatory strategies, prepare submission dossiers, and liaise with health authorities while collaborating with R&D, QA, and commercial teams.

The role requires a strategic thinker with strong attention to detail, proven submission

Qualifications

Master's degree or PhD in pharmacy, chemistry, biology or related field.
Minimum of 6 years in pharmaceutical regulatory affairs.
Proven track record of regulatory submissions and approvals.
Expert knowledge of SAHPRA and major international markets (FDA, EMA).

Responsibilities

Develop regulatory strategies for product registrations and lifecycle management.
Prepare and submit CTD-style dossiers to authorities.
Serve as primary liaison with regulatory agencies.
Monitor evolving regulations and advise on impact.
Guide labeling, advertising, and promotional materials for compliance.
Support cross-functional teams with regulatory guidance.
Manage variations, renewals, and annual reporting.