Regulatory Affairs Specialist - Pharmaceutical

Placements24; Rustenburg; Híbrido; ZAR 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Comprehensive medical aid

Retirement fund contributions

Professional development opportunities

Descripción de la vacante

Placements24 in Rustenburg is seeking a Regulatory Affairs Specialist to ensure product compliance with SAHPRA and international regulations. The role involves preparing submission dossiers, monitoring evolving guidelines, and coordinating with internal teams for approvals.

The position offers hybrid work, balancing in-office collaboration with remote flexibility, and a focus on maintaining rigorous regulatory standards across the product lifecycle.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related discipline.
• Proven experience in regulatory affairs within the pharmaceutical or medical device industry.
• Solid understanding of South African and international regulatory landscapes (SAHPRA, FDA, EMA).
• Experience in preparing regulatory submission dossiers (CTD format).
• Excellent written and verbal communication skills, with strong attention to detail.

Responsabilidades

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals to health authorities.
• Monitor and interpret evolving regulatory requirements and guidelines affecting the pharmaceutical industry.
• Liaise with regulatory agencies, internal departments, and external partners to address inquiries and facilitate approvals.
• Ensure compliance with relevant legislation, GMP, and quality standards across all product-related activities.
• Maintain regulatory databases and ensure all documentation is current and readily accessible.

Conocimientos

Regulatory affairs

Dossier preparation

Stakeholder communication

Educación

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Descripción del empleo

About the Role

Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their team in Rustenburg. You will be responsible for ensuring that all pharmaceutical products comply with national and international regulations, facilitating the approval process for new drugs and medical devices. This hybrid role offers a balance of in-office collaboration and remote flexibility. You will be a key player in navigating complex regulatory pathways, preparing submission dossiers, and maintaining compliance throughout the product lifecycle. This position is ideal for an individual with a strong grasp of regulatory frameworks and a commitment to ensuring product safety and efficacy.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals to health authorities.
• Monitor and interpret evolving regulatory requirements and guidelines affecting the pharmaceutical industry.
• Liaise with regulatory agencies, internal departments, and external partners to address inquiries and facilitate approvals.
• Ensure compliance with relevant legislation, GMP, and quality standards across all product-related activities.
• Maintain regulatory databases and ensure all documentation is current and readily accessible.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Proven experience in regulatory affairs within the pharmaceutical or medical device industry.
• Solid understanding of South African and international regulatory landscapes (e.g., SAHPRA, FDA, EMA).
• Experience in preparing regulatory submission dossiers (e.g., CTD format).
• Excellent written and verbal communication skills, with strong attention to detail.

Benefits

• Competitive salary package commensurate with experience.
• Hybrid work model combining remote and in-office work.
• Comprehensive medical aid and retirement fund contributions.
• Opportunities for professional development and further training in regulatory science.
• A collaborative and supportive work environment focused on achieving regulatory excellence.