Senior Regulatory Affairs Specialist

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life assurance

Retirement savings plan

Professional development opportunities

Job summary

Placements24 in Polokwane, Limpopo is seeking a Senior Regulatory Affairs Specialist to navigate the global regulatory landscape, prepare and submit regulatory dossiers, and liaise with health authorities to secure timely approvals.

You will provide strategic regulatory guidance to product development, clinical, and commercial teams, monitor evolving guidelines, manage post-approval activities, and maintain regulatory documentation within a fast-paced, collaborative environment.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission requirements (ICH, FDA, EMA, SAHPRA).
• Proven experience in preparing and managing regulatory dossiers.
• Strong analytical, organizational, and project management skills.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency in regulatory information management systems is a plus.
• Experience interacting directly with regulatory health authorities.
• A proactive approach to problem-solving and risk mitigation.

Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) for product registrations in various global markets.
• Act as the primary point of contact with regulatory agencies (e.g., SAHPRA, FDA, EMA).
• Provide strategic regulatory guidance to product development, clinical, and commercial teams.
• Monitor and interpret regulatory guidelines and advise on their impact on company strategy.
• Manage post-approval regulatory activities, including variations, renewals, and lifecycle management.
• Review promotional materials and labeling for regulatory compliance.
• Conduct regulatory intelligence activities to stay informed of evolving requirements.
• Participate in regulatory inspections and audits.
• Collaborate with cross-functional teams to ensure alignment on regulatory strategies.
• Maintain regulatory documentation and databases.

Skills

Regulatory affairs

Project management

Analytical thinking

Communication skills

Independent worker

Education

Bachelor's or Master's degree in Life Sciences

Tools

Regulatory information systems

Job description

About the Role

Our client, a distinguished pharmaceutical company with a growing portfolio of innovative medicines, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their dedicated team in **Polokwane, Limpopo**. This role is essential for navigating the complex global regulatory landscape, ensuring that our client's products receive timely approvals and maintain compliance throughout their lifecycle. The Senior Regulatory Affairs Specialist will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance to internal teams. The ideal candidate possesses a strong understanding of regulatory requirements across different regions and a proven ability to manage multiple submission projects concurrently. This is a key position in **Polokwane, Limpopo**, contributing directly to making essential medicines accessible to patients worldwide. We are looking for a proactive, detail-oriented professional who thrives in a dynamic environment and is committed to upholding the highest standards of regulatory excellence. Your expertise will be crucial in advancing our client's mission to improve global health outcomes.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) for product registrations in various global markets.
• Act as the primary point of contact with regulatory agencies (e.g., SAHPRA, FDA, EMA).
• Provide strategic regulatory guidance to product development, clinical, and commercial teams.
• Monitor and interpret regulatory guidelines and advise on their impact on company strategy.
• Manage post-approval regulatory activities, including variations, renewals, and lifecycle management.
• Review promotional materials and labeling for regulatory compliance.
• Conduct regulatory intelligence activities to stay informed of evolving requirements.
• Participate in regulatory inspections and audits.
• Collaborate with cross-functional teams to ensure alignment on regulatory strategies.
• Maintain regulatory documentation and databases.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission requirements (e.g., ICH, FDA, EMA, SAHPRA).
• Proven experience in preparing and managing regulatory dossiers.
• Strong analytical, organizational, and project management skills.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency in regulatory information management systems is a plus.
• Experience interacting directly with regulatory health authorities.
• A proactive approach to problem-solving and risk mitigation.

Benefits

Our client offers a competitive salary, a comprehensive benefits package including health, dental, and vision insurance, life assurance, and a retirement savings plan. We are committed to professional development, providing opportunities for advanced training, conference attendance, and career growth within our **Polokwane, Limpopo** office. Employees benefit from a collaborative and dynamic work environment focused on innovation and patient well-being. This role offers a unique chance to influence regulatory strategies and contribute significantly to global health initiatives. Specific details regarding compensation and benefits will be discussed during the interview process.