Remote Pharmaceutical Regulatory Affairs Associate

Placements24; Klerksdorp; Hybrid; ZAR 360,000 - 600,000; Full time

Benefits offered by this job

Fully remote work opportunity

Health, dental, and vision insurance

Professional development opportunities

On-the-job training

Job summary

Placements24 seeks a diligent Remote Pharmaceutical Regulatory Affairs Associate to support regulatory operations from anywhere in Klerksdorp. You will assist in preparing and managing regulatory documentation for product approvals across international markets, ensuring submissions meet deadlines.

Remote work, you will collaborate with the regulatory team, maintain databases, review CTD modules, and stay updated on regulatory changes.

Qualifications

• Bachelor’s degree in a scientific field as listed.
• 1–3 years in pharmaceutical regulatory affairs or related areas.
• Familiarity with regulatory guidelines and submission processes is a plus.
• Strong organizational skills and meticulous attention to detail.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office Suite.

Responsibilities

• Assist in preparation, assembly, and review of regulatory submission docs (CTD modules).
• Maintain regulatory databases and filing systems for submissions and approvals.
• Support the team by responding to queries from health authorities and stakeholders.
• Conduct literature searches and regulatory research for submissions.
• Ensure labeling and packaging compliance with regulatory requirements.

Skills

Communication skills

Organizational skills

Attention to detail

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Tools

Microsoft Office Suite

Job description

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.