Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; George; Remote; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Remote work setup package

Global exposure

Flexible hours

Job summary

Placements24 is seeking a Remote Pharmaceutical Regulatory Affairs Specialist to drive global regulatory compliance from George. You will prepare and submit regulatory dossiers, monitor guidelines, and collaborate with R&D, Manufacturing, and Marketing to ensure timely submissions.

The role requires a Phamacy/Life Sciences background with 5+ years in regulatory affairs, ICH/GMP/GCP knowledge, and strong communication skills.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated success in preparing and submitting regulatory applications in key markets (e.g., SAHPRA, FDA, EMA).
• In-depth knowledge of ICH guidelines, GMP, GCP, and relevant pharmaceutical regulations.
• Excellent written and verbal communication skills, with a strong ability to convey complex regulatory information clearly and concisely.
• Proficiency in regulatory information management systems and standard office software; experience with electronic submission tools is advantageous.

Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new drug applications, variations, and renewals to various health authorities globally.
• Monitor and interpret evolving regulatory landscapes and guidelines relevant to the pharmaceutical industry, providing strategic insights.
• Liaise with internal departments and external partners to ensure timely and accurate regulatory submissions.
• Manage post-approval regulatory commitments, including variations, annual reports, and safety updates.
• Provide regulatory guidance and support to project teams throughout the drug development process.
• Maintain regulatory databases and documentation systems to ensure compliance and accessibility of critical information for regulatory strategy.

Education

Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline

Job description

About the Role

Our client is seeking a dedicated Remote Pharmaceutical Regulatory Affairs Specialist to enhance their global compliance efforts from George . This position is crucial for ensuring that our client's pharmaceutical products meet all national and international regulatory requirements, facilitating smooth market access and maintaining compliance throughout the product lifecycle. You will work independently and collaborate with cross-functional teams remotely, contributing to strategic regulatory submissions and policy interpretations. This role offers the flexibility of remote work combined with the opportunity to make a significant impact on a company committed to innovation and patient well-being worldwide, operating in a sector dedicated to advancing healthcare solutions.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new drug applications, variations, and renewals to various health authorities globally.
• Monitor and interpret evolving regulatory landscapes and guidelines relevant to the pharmaceutical industry, providing strategic insights.
• Liaise with internal departments (e.g., R&D, Manufacturing, Marketing) and external partners to ensure timely and accurate regulatory submissions.
• Manage post-approval regulatory commitments, including variations, annual reports, and safety updates.
• Provide regulatory guidance and support to project teams throughout the drug development process.
• Maintain regulatory databases and documentation systems to ensure compliance and accessibility of critical information for regulatory strategy .

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated success in preparing and submitting regulatory applications in key markets (e.g., SAHPRA, FDA, EMA).
• In-depth knowledge of ICH guidelines, GMP, GCP, and relevant pharmaceutical regulations.
• Excellent written and verbal communication skills, with a strong ability to convey complex regulatory information clearly and concisely.
• Proficiency in regulatory information management systems and standard office software; experience with electronic submission tools is advantageous.

Benefits

• Highly competitive salary with performance-based incentives.
• Comprehensive remote work setup support and benefits package.
• Opportunity for significant professional growth and international exposure in regulatory affairs.
• Flexible working hours that accommodate a home-based environment.
• Contribution to a company mission focused on improving global health outcomes through compliant pharmaceutical products.