Regulatory Affairs Associate

Placements24; Polokwane; Hybrid; ZAR 350,000 - 550,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Fully remote

Mentorship and training

Exposure to multiple markets

Job summary

Placements24 seeks a Regulatory Affairs Associate to join a fully remote regulatory team. You will aid in preparing and maintaining regulatory filings for pharmaceutical products, ensuring timelines and standards are met.

You will collaborate with senior regulators, research guidelines for various markets, and update labeling to comply with regulations. Strong organization and communication are essential in a remote setting.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• 1–3 years of regulatory affairs experience in pharma.
• Understanding of regulatory requirements and guidelines.

Responsibilities

• Assist in preparation and compilation of regulatory submission documents.
• Support maintenance of regulatory filings and compliance.
• Research regulatory guidelines for various markets.
• Review/update product labeling and artwork for compliance.
• Liaise with R&D and Quality to gather submission information.
• Track submission statuses and respond to agency queries under supervision.

Skills

Strong organizational skills

Attention to detail

Excellent written and verbal comms

Ability to work independently

Education

Bachelor's degree in Pharmacy, Life Sciences, or related field

Job description

About the Role

Our client is seeking an enthusiastic and detail-oriented Regulatory Affairs Associate to join their fully remote regulatory team. This role is crucial for supporting the preparation, submission, and maintenance of regulatory filings for pharmaceutical products. You will work closely with senior regulatory professionals, contributing to compliance efforts and ensuring that submissions meet all required standards and timelines. This position is ideal for an individual looking to grow their career in pharmaceutical regulatory affairs within a flexible, remote-first environment. Your contributions will directly support the company's mission to bring vital medicines to patients efficiently and safely.

Key Responsibilities

• Assist in the preparation and compilation of regulatory submission documents (e.g., marketing authorization applications, variations).
• Support the maintenance of regulatory filings, ensuring all documentation is up-to-date and compliant.
• Conduct research on regulatory guidelines and requirements for various markets.
• Review and update product labeling and artwork to ensure compliance with regulatory standards.
• Liaise with internal departments (e.g., R&D, Quality) to gather necessary information for regulatory submissions.
• Track submission statuses and respond to regulatory agency queries under supervision.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• 1-3 years of experience in regulatory affairs or a related field within the pharmaceutical industry.
• Basic understanding of pharmaceutical regulatory requirements and guidelines.
• Strong organizational skills and meticulous attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently, manage time effectively, and meet deadlines in a remote setting.

Benefits

• Competitive annual salary with opportunities for review based on performance.
• Comprehensive health and wellness benefits.
• A fully remote work arrangement offering flexibility and work-life balance.
• Mentorship and training from experienced regulatory affairs professionals.
• Exposure to a wide range of regulatory projects and markets.