Regulatory Affairs Specialist - Pharmaceuticals

Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their globally distributed team, operating in a fully remote capacity. This role is crucial for ensuring compliance with all relevant health authority regulations for pharmaceutical products. You will be responsible for preparing, reviewing, and submitting regulatory documentation, and for managing interactions with regulatory agencies worldwide. This is an ideal opportunity for a self-motivated professional who thrives in an independent work setting, possesses excellent attention to detail, and is passionate about navigating the complex landscape of pharmaceutical regulations to bring vital medicines to market efficiently and compliantly.

• Prepare and submit regulatory submissions (e.g., INDs, NDAs, CTDs) to health authorities globally.
• Review and approve product labeling, promotional materials, and advertising for regulatory compliance.
• Interpret and apply global regulatory guidelines and regulations to product development and lifecycle management.
• Serve as a primary contact with regulatory agencies for inquiries and submissions.
• Develop and implement regulatory strategies for new product development and post-approval activities.
• Monitor changes in the regulatory environment and assess their impact on the company's products and operations.

• Bachelor's or Master's degree in a scientific, pharmaceutical, or related discipline.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs .
• In-depth knowledge of global regulatory requirements (FDA, EMA, SAHPRA, etc.).
• Experience with regulatory submission software and electronic document management systems.
• Strong understanding of drug development processes and product lifecycle management.
• Excellent written and verbal communication skills, with a keen eye for detail.

• Competitive salary and performance-based incentives.
• Fully remote work environment with flexible hours.
• Comprehensive health, dental, and vision insurance.
• Generous allowance for professional development and continuing education.
• Opportunity to work on diverse projects and contribute to global health initiatives.