Senior Regulatory Affairs Specialist — Global Submissions & Strategy

Placements24; Polokwane; Hybride; ZAR 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

Life assurance

Retirement savings plan

Professional development opportunities

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory affairs

Project management

Analytical thinking

Communication skills

Independent worker

Formation

Bachelor's or Master's degree in Life Sciences

Outils

Regulatory information systems

Description du poste

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.