Remote Pharma Regulatory Affairs Specialist

Placements24

Rustenburg

Hybrid

ZAR 550,000 - 900,000

Full time

2 days ago

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Benefits offered by this job

Competitive salary

Remote work allowance

Health and wellness benefits

Professional development

Flexible remote hours

Job summary

Placements24 is seeking a highly skilled Regulatory Affairs Specialist to join a remote team, based in Rustenburg. You will ensure compliance with SAHPRA and international pharmaceutical regulations, prepare and submit dossiers, and advise across the business from a remote setting.

You will liaise with health authorities, monitor evolving regulatory landscapes, and support lifecycle management for drug products and medical devices while benefiting from a strong focus on work-life balance and

Qualifications

Bachelor's degree in Pharmacy, Chemistry, Biology or related field required.
Minimum 4 years of experience in pharmaceutical regulatory affairs.
Strong knowledge of SAHPRA regulations and submissions.

Responsibilities

Prepare, review, and submit regulatory dossiers for drug product approvals and variations (e.g., CTD, eCTD).
Liaise effectively with regulatory authorities such as SAHPRA.
Monitor evolving global regulatory landscapes and advise the business accordingly.
Ensure company products and processes comply with current pharmaceutical regulations.
Manage post-approval regulatory activities, including annual reports and supplements.
Support development of regulatory strategies for new product launches and lifecycle management.