Remote Pharmaceutical Regulatory Affairs Specialist
Rustenburg, 0202, South Africa
Listed on 2026-09-21
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Pharmaceutical
Healthcare Compliance, Medical Science Liaison -
Healthcare
Healthcare Compliance, Medical Science Liaison
About the Role
Our client is seeking a dedicated and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist to join their expanding operations. This position is crucial for ensuring that all products and processes comply with national and international pharmaceutical regulations. Working remotely from Rustenburg or any suitable location, you will be responsible for preparing, submitting, and maintaining regulatory documentation, liaising with health authorities, and providing expert guidance on regulatory strategies.
This role offers a unique opportunity to make a significant impact on regulatory compliance and market access for our client's innovative pharmaceutical products from the convenience of your home office, contributing to a global health initiative.
- Prepare, review, and submit regulatory filings (e.g., IND, NDA, MAA) to relevant health authorities worldwide.
- Maintain existing regulatory registrations and ensure ongoing compliance with applicable regulations and guidelines.
- Interpret regulatory requirements and provide strategic guidance to project teams on regulatory strategy.
- Communicate and negotiate with regulatory agencies, responding to inquiries and addressing regulatory deficiencies.
- Monitor changes in the regulatory landscape and assess their impact on company products and operations.
- Manage post-approval lifecycle activities, including variations, renewals, and reporting.
- Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global pharmaceutical regulations (FDA, EMA, SAHPRA, etc.).
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote setting.
- Highly competitive salary and performance-based incentives.
- Fully remote work environment with flexible hours.
- Comprehensive health and wellness benefits package.
- Professional development opportunities, including regulatory training and conferences.
- Opportunity to work with cutting-edge pharmaceutical products and contribute to global health.
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