Senior Pharmaceutical Regulatory Affairs Specialist
Rustenburg, 0202, South Africa
Listed on 2026-09-12
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Healthcare
Healthcare Compliance, Medical Science Liaison -
Pharmaceutical
Healthcare Compliance, Medical Science Liaison
About the Role
Our client seeks a seasoned Senior Pharmaceutical Regulatory Affairs Specialist to provide expert guidance and ensure compliance with regulatory requirements for their products manufactured and distributed in Rustenburg and internationally. This role is crucial for navigating the complex landscape of pharmaceutical regulations, ensuring timely submissions, and maintaining positive relationships with health authorities. You will be responsible for developing regulatory strategies, preparing submission dossiers, and advising project teams on regulatory implications.
This is an ideal position for a proactive professional who thrives on ensuring global compliance within the dynamic pharmaceutical industry, working remotely with significant autonomy.
- Develop and execute regulatory strategies for new product registrations and lifecycle management in various global markets.
- Prepare, review, and submit regulatory documentation (e.g., CTD, IND, NDA) to health authorities such as the SAHPRA, FDA, and EMA.
- Liaise with regulatory agencies, responding to queries and facilitating agency inspections and interactions.
- Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
- Provide regulatory input and support to product development, manufacturing, and commercial teams.
- Ensure all promotional materials and labeling comply with relevant regulatory guidelines.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum 5-7 years of experience in pharmaceutical regulatory affairs, with a strong understanding of South African and international regulatory requirements.
- Proven experience in preparing and submitting registration dossiers (e.g., Module 3 of the CTD).
- Familiarity with regulatory submission software and databases.
- Excellent written and verbal communication skills, with the ability to negotiate effectively with regulatory bodies.
- Competitive annual salary with performance-based incentives.
- Remote work flexibility, allowing you to work from anywhere.
- Comprehensive healthcare, retirement planning, and life insurance.
- Opportunities for professional growth, including attending international regulatory conferences.
- A supportive and collaborative remote team environment focused on global health solutions.
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