Remote Pharmaceutical Regulatory Affairs Associate

About the Role

Our client is seeking a diligent and organized Remote Pharmaceutical Regulatory Affairs Associate to support their regulatory operations from anywhere in Klerksdorp . This position is crucial for assisting in the preparation and management of regulatory documentation required for product approvals and compliance across various international markets. Working from a remote setting, you will collaborate closely with the regulatory affairs team and other departments to ensure that all submissions meet the highest standards and deadlines. This role offers a fantastic entry point for individuals passionate about pharmaceutical compliance and looking for a flexible, home-based career.

Key Responsibilities

• Assist in the preparation, assembly, and review of regulatory submission documentation (e.g., modules of the Common Technical Document - CTD).
• Maintain regulatory databases and filing systems, ensuring accurate and up-to-date records of submissions and approvals.
• Support the regulatory team in responding to queries from health authorities and internal stakeholders.
• Conduct literature searches and regulatory research to support submission activities and stay informed of regulatory changes.
• Ensure compliance of product labeling and packaging materials with relevant regulatory requirements.
• Coordinate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to gather necessary information for regulatory filings.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• 1-3 years of experience in pharmaceutical regulatory affairs or a closely related field (e.g., Quality Assurance, R&D documentation).
• Familiarity with pharmaceutical regulatory guidelines and submission processes is beneficial.
• Strong organizational skills and meticulous attention to detail.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite and an aptitude for learning new software systems.

Benefits

• Competitive salary for an Associate-level position.
• Fully remote work opportunity providing excellent work-life balance.
• Comprehensive health, dental, and vision insurance benefits.
• Opportunities for professional development and on-the-job training in regulatory affairs.
• A supportive and collaborative remote team environment.