Remote Pharmaceutical Regulatory Affairs Specialist

Our client is seeking a highly organized and knowledgeable Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This fully remote position is integral to ensuring compliance with the complex and ever-evolving regulatory landscape of the pharmaceutical industry worldwide. You will be responsible for preparing, reviewing, and submitting regulatory documentation, liaising with health authorities, and providing strategic regulatory guidance to product development teams.

The ideal candidate is adept at navigating international regulatory requirements and possesses excellent communication skills for effective remote collaboration.

• Prepare and compile high-quality regulatory submission dossiers (e.g., NDAs, MAAs, variations) for submission to global health authorities.
• Review and approve labeling, promotional materials, and other regulated content to ensure compliance.
• Liaise with regulatory agencies, responding to queries and managing the submission process through approval.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Monitor regulatory intelligence and advise internal teams on changes in regulatory requirements.
• Maintain regulatory databases and ensure accurate record-keeping of all regulatory activities.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field;
  Master's degree preferred.
• Minimum of 4 years of experience in Pharmaceutical Regulatory Affairs .
• Strong understanding of global regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Proven experience in preparing and submitting various regulatory dossiers.
• Excellent written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple projects effectively in a remote setting.

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Flexible working hours and a fully remote work arrangement.
• Generous professional development budget for training and certifications.
• A supportive and collaborative international team environment.