Pharmaceutical Regulatory Affairs Specialist

Placements24; Richards Bay; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Fully remote

Flexible working hours

Health insurance

Professional development

Job summary

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist to ensure products meet global regulatory requirements. This fully remote role is based in Richards Bay, KwaZulu-Natal, offering flexibility and autonomy.

You will prepare, submit, and maintain regulatory dossiers (CTD/MAA/ANDA) to authorities such as FDA, EMA and SAHPRA, manage submissions lifecycle, and provide regulatory guidance to R&D, quality and marketing.

Qualifications

• 4–6 years of direct regulatory affairs experience.
• Experience preparing regulatory dossiers for major authorities (FDA, EMA, SAHPRA).
• Knowledge of ICH guidelines and submissions formats.
• Strong written and verbal communication skills.
• Ability to work independently in a remote setting.

Responsibilities

• Prepare and submit regulatory dossiers (CTD, ANDA, MAA).
• Manage lifecycle of regulatory submissions (amendments, variations, renewals).
• Liaise with regulatory agencies and respond to queries during reviews.
• Ensure compliance with cGMP, GCP, and related regs.
• Review labeling, promotional materials, and technical docs for compliance.
• Conduct regulatory intelligence to stay updated on guidelines.
• Provide regulatory guidance to R&D, QA, and marketing.
• Assess regulatory implications of product changes and manufacturing changes.
• Maintain regulatory databases and records.

Skills

Regulatory affairs

Regulatory dossiers

Regulatory submissions

Communication skills

Project management

Analytical skills

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's degree in Life sciences

Tools

Regulatory information systems

Job description

About the Role

Our client, a dynamic and expanding pharmaceutical company, is seeking a diligent and experienced Pharmaceutical Regulatory Affairs Specialist to join their team. This role is integral to ensuring that our client's products meet all necessary regulatory requirements for market approval and maintenance across various territories. While the role is based in the broader region of Richards Bay, KwaZulu-Natal , this specific position is structured as fully remote, offering flexibility and autonomy. You will be responsible for preparing, submitting, and maintaining regulatory documentation for new and existing pharmaceutical products. This requires a deep understanding of global regulatory landscapes, including those of key markets like the US, Europe, and South Africa. The ideal candidate will possess strong analytical skills, meticulous attention to detail, and the ability to effectively communicate complex regulatory information. This is an excellent opportunity to contribute to global health by facilitating access to essential medicines.

Key Responsibilities

• Prepare and submit regulatory dossiers (e.g., CTD, ANDA, MAA) to health authorities worldwide.
• Manage the lifecycle of regulatory submissions, including amendments, variations, and renewals.
• Liaise with regulatory agencies and respond to queries during the review process.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulations.
• Review and approve labeling, promotional materials, and technical documentation for regulatory compliance.
• Conduct regulatory intelligence activities to stay updated on evolving regulations and guidelines.
• Provide regulatory guidance and support to internal teams, including R&D, quality, and marketing.
• Assess the regulatory implications of product changes and manufacturing process modifications.
• Maintain accurate regulatory databases and records.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A minimum of 4-6 years of direct experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory dossiers to major health authorities (e.g., FDA, EMA, SAHPRA).
• In-depth knowledge of pharmaceutical regulations, guidelines (ICH), and submission formats.
• Excellent understanding of the drug development process and product lifecycle management.
• Strong analytical, organizational, and project management skills.
• Exceptional written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in regulatory information management systems and standard office software.
• Ability to work independently and manage multiple projects simultaneously in a remote setting.

Benefits

• This fully remote role offers a competitive salary, flexible working hours, and the opportunity to work from anywhere.
• Our client provides a comprehensive benefits package, including health insurance, paid time off, and professional development opportunities.
• While the operational base is near Richards Bay, KwaZulu-Natal , you will enjoy the autonomy of a remote position.
• Join a growing company that values its employees' contributions and offers a challenging yet rewarding career path in the pharmaceutical industry.
• This role is ideal for an experienced professional seeking a remote work arrangement without compromising on career impact.