Senior Regulatory Affairs Specialist
Cape Town, 7561, South Africa
Listed on 2026-09-28
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Pharmaceutical
Healthcare Compliance -
Healthcare
Healthcare Compliance
About the Role
Our client, a forward-thinking pharmaceutical company, is actively seeking a dedicated Senior Regulatory Affairs Specialist to join their fully remote team. In this pivotal role, you will be instrumental in guiding drug development programs through complex regulatory landscapes across various global markets. You will develop and execute regulatory strategies, prepare and submit regulatory applications, and serve as the primary point of contact with health authorities.
This position offers an exceptional opportunity for a seasoned professional to shape regulatory pathways for innovative therapies from the comfort of their home office, contributing to a company culture that champions innovation, compliance, and employee well-being.
- Develop and implement comprehensive global regulatory strategies for drug development programs.
- Prepare, review, and submit regulatory dossiers, including INDs, NDAs, and variations, to health authorities worldwide.
- Liaise directly with regulatory agencies (e.g., SAHPRA, FDA, EMA) to address inquiries and facilitate approvals.
- Provide regulatory guidance and support to R&D, clinical, and commercial teams throughout the product lifecycle.
- Monitor and interpret evolving regulatory guidelines and advise the organization on compliance requirements.
- Conduct regulatory due diligence for potential collaborations and acquisitions.
- Master's or PhD in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets.
- Expert knowledge of international regulatory guidelines (ICH, SAHPRA, FDA, EMA).
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to work autonomously and manage multiple projects in a remote work environment .
- Highly competitive salary with excellent bonus potential.
- Comprehensive remote health, dental, and vision benefits.
- Generous provision for home office setup and professional development.
- Flexible working hours to accommodate a remote-first lifestyle.
- Significant impact on product development and company strategy.
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