Regulatory Affairs Specialist - Pharmaceuticals

Our client is seeking a sharp and knowledgeable Regulatory Affairs Specialist to manage regulatory submissions and compliance for their pharmaceutical products. This position is fully remote, allowing you to contribute to global health initiatives from the comfort of your home. You will play a key role in ensuring our products meet the rigorous standards set by health authorities worldwide. This involves preparing and submitting regulatory documentation, maintaining compliance, and staying informed about evolving regulations.

The ideal candidate is detail-oriented, proactive, and possesses strong communication skills to effectively navigate the complex landscape of pharmaceutical regulation.

• Prepare, review, and submit regulatory dossiers for new drug applications (NDAs) and variations.
• Ensure compliance with relevant regulatory guidelines (e.g., FDA, EMA, SAHPRA) for product registration and maintenance.
• Liaise with regulatory agencies, responding to queries and managing submissions.
• Monitor changes in the regulatory landscape and assess their impact on company products.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.
• Collaborate with R&D, manufacturing, and marketing teams on regulatory strategies.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of global pharmaceutical regulatory requirements and submission processes.
• Experience with electronic submission systems (e.g., eCTD).
• Strong analytical, organizational, and project management skills.
• Excellent written and verbal communication skills, with the ability to work independently in a remote setting.

• Competitive salary and performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• Flexible paid time off policy.
• Retirement savings plan.
• Professional development and training in regulatory affairs.
• Fully remote work environment fostering autonomy and work-life balance.