Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Fully remote work

Health and wellness benefits

Professional development opportunities

Global health impact

Job summary

Placements24 is seeking a dedicated Remote Pharmaceutical Regulatory Affairs Specialist to ensure compliance with global pharma regulations. You will prepare, submit, and maintain regulatory filings from your home office, liaising with authorities and guiding regulatory strategy.

The role requires 5+ years in regulatory affairs, deep knowledge of FDA/EMA/SAHPRA, and strong communication to support market access for innovative products worldwide.

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences; advanced degree preferred.
• Minimum 5 years in pharmaceutical regulatory affairs.
• Experience with FDA, EMA, SAHPRA regulatory submissions.

Responsibilities

• Prepare, review, and submit regulatory filings (IND, NDA, MAA) to authorities worldwide.
• Maintain registrations and ensure ongoing regulatory compliance.
• Interpret requirements and guide project teams on regulatory strategy.
• Communicate with regulatory agencies and address deficiencies.
• Monitor regulatory landscape and assess impact on products.
• Manage post-approval lifecycle activities including variations and renewals.

Skills

Regulatory submissions

Global regulations

Regulatory strategy

Remote work capability

Education

Bachelor's degree in Pharmacy

Job description

About the Role

Our client is seeking a dedicated and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist to join their expanding operations. This position is crucial for ensuring that all products and processes comply with national and international pharmaceutical regulations. Working remotely from Rustenburg or any suitable location, you will be responsible for preparing, submitting, and maintaining regulatory documentation, liaising with health authorities, and providing expert guidance on regulatory strategies. This role offers a unique opportunity to make a significant impact on regulatory compliance and market access for our client's innovative pharmaceutical products from the convenience of your home office, contributing to a global health initiative.

Key Responsibilities

• Prepare, review, and submit regulatory filings (e.g., IND, NDA, MAA) to relevant health authorities worldwide.
• Maintain existing regulatory registrations and ensure ongoing compliance with applicable regulations and guidelines.
• Interpret regulatory requirements and provide strategic guidance to project teams on regulatory strategy.
• Communicate and negotiate with regulatory agencies, responding to inquiries and addressing regulatory deficiencies.
• Monitor changes in the regulatory landscape and assess their impact on company products and operations.
• Manage post-approval lifecycle activities, including variations, renewals, and reporting.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of global pharmaceutical regulations (FDA, EMA, SAHPRA, etc.).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote setting.

Benefits

• Highly competitive salary and performance-based incentives.
• Fully remote work environment with flexible hours.
• Comprehensive health and wellness benefits package.
• Professional development opportunities, including regulatory training and conferences.
• Opportunity to work with cutting-edge pharmaceutical products and contribute to global health.