Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Mtubatuba Local Municipality; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Flexible remote work

Generous leave

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to navigate global regulatory requirements for pharmaceutical products. This remote role focuses on preparing dossiers, liaising with health authorities, and providing strategic guidance to support timely approvals and market access.

The ideal candidate has a Pharmacy or Life Sciences background, 5+ years of regulatory experience, and strong written and verbal communication.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's preferred.

Responsibilities

• Prepare, review, and submit regulatory documentation for NDAs and variations in various international markets.
• Liaise with global health authorities (FDA, EMA, SAHPRA) to facilitate communication and respond to queries.
• Monitor and interpret evolving regulatory guidelines and advise the organization on strategic compliance measures.
• Ensure that product labeling and promotional materials comply with regulatory requirements.
• Conduct regulatory intelligence activities to identify potential risks and opportunities.
• Support regulatory aspects of post-market surveillance and lifecycle management of products.

Education

Bachelor's degree in Pharmacy/Life Sciences

Master's degree preferred

Job description

About the Role

Our client is looking for a highly knowledgeable Regulatory Affairs Specialist to join their team and work remotely, focusing on navigating the complex global regulatory landscape for pharmaceutical products. This role is essential for ensuring that the company's products comply with all applicable laws and regulations in target markets. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic guidance on regulatory matters. The ideal candidate will possess strong analytical skills, a deep understanding of regulatory submission processes, and the ability to stay abreast of evolving regulatory requirements to facilitate timely product approvals and market access globally, contributing to the company's international growth and compliance objectives.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs) and variations/amendments in various international markets.
• Liaise with global health authorities (e.g., FDA, EMA, SAHPRA) to facilitate communication and respond to queries.
• Monitor and interpret evolving regulatory guidelines and advise the organization on strategic compliance measures.
• Ensure that product labeling and promotional materials comply with regulatory requirements.
• Conduct regulatory intelligence activities to identify potential risks and opportunities.
• Support regulatory aspects of post-market surveillance and lifecycle management of products.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; Master's degree or equivalent experience preferred.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and filing regulatory submissions in key global markets.
• In-depth knowledge of international pharmaceutical regulations and guidelines (ICH, FDA, EMA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage timelines, and prioritize tasks effectively in a remote environment.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Flexible remote working environment.
• Generous paid vacation and holiday leave.
• Opportunities for continuous learning and professional development.
• A dynamic and global outlook on pharmaceutical regulatory strategy.