Regulatory Affairs Specialist - Drug Registration

Placements24; Durban; Hybride; ZAR 900 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Health insurance

Remote work flexibility

Professional development

Résumé du poste

Placements24 seeks a Regulatory Affairs Specialist to join our Durban-based team. You will navigate SAHPRA and global regulations, prepare and submit dossiers, and provide strategic regulatory guidance to support product development and lifecycle management.

The role offers fully remote work flexibility, with opportunities to influence regulatory strategy across multiple markets and ensure timely approvals for essential medicines.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field
• 4+ years in regulatory affairs within pharma
• Knowledge of SAHPRA and international regs (EMA, FDA) is desirable
• Experience preparing regulatory dossiers (CTD)
• Strong understanding of drug development and manufacturing
• Excellent written and verbal communication, detail-oriented
• Ability to manage multiple projects and meet deadlines
• Proficiency in regulatory information systems

Responsabilités

• Prepare, review, and submit regulatory dossiers for NDAs and variations in SA and target markets
• Interpret regulatory requirements and keep internal stakeholders informed
• Liaise with regulatory agencies, respond to queries, facilitate approvals
• Develop and implement regulatory strategies to support development and lifecycle management
• Ensure compliance with SAHPRA and international health authority regulations
• Maintain regulatory databases and records of submissions and approvals
• Review and approve promotional materials and labeling for compliance
• Participate in cross-functional meetings to provide regulatory input
• Monitor regulatory changes and assess impact on products and operations

Connaissances

Regulatory affairs

Dossier submission

Regulatory strategy

Stakeholder communication

Project management

Formation

Bachelor's/Master's degree in Pharmacy/chemistry/biology

Description du poste

About the Role

Our client, a prominent player in the global pharmaceutical landscape, is looking for a skilled Regulatory Affairs Specialist to join their dedicated team in Durban, KwaZulu-Natal. This role is pivotal in ensuring that our client's pharmaceutical products meet all national and international regulatory standards for market approval and continued compliance. You will be instrumental in navigating the complex regulatory pathways, preparing and submitting documentation to health authorities, and providing strategic regulatory guidance. This is a fantastic chance to contribute to bringing essential medicines to patients while working in a challenging yet rewarding environment in the scenic coastal city of Durban. The role offers the flexibility of remote work, allowing you to manage your work from anywhere.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new drug applications (NDAs) and variations to existing product registrations in South Africa and other target markets.
• Interpret and communicate regulatory requirements, guidelines, and updates to relevant internal stakeholders.
• Act as the primary liaison with regulatory agencies, responding to queries and facilitating the approval process.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Ensure compliance with all applicable regulations, including those set forth by SAHPRA and other international health authorities.
• Maintain regulatory databases and ensure accurate and up-to-date records of all regulatory submissions and approvals.
• Review and approve promotional materials and labeling to ensure regulatory compliance.
• Participate in cross-functional team meetings to provide regulatory input on product development and commercialization strategies.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of South African pharmaceutical regulations (SAHPRA) and experience with other international regulatory requirements (e.g., EMA, FDA) is highly desirable.
• Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
• Strong understanding of drug development processes and pharmaceutical manufacturing.
• Excellent written and verbal communication skills, with strong attention to detail and accuracy.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines.
• Proficiency in regulatory information management systems and standard office software.
• Adaptability and a proactive approach to problem-solving in a dynamic regulatory environment.

Benefits

• Our client provides a competitive salary and a comprehensive benefits package, including excellent health insurance, paid time off, and retirement savings contributions.
• Opportunities for professional development and continuous learning are prioritized, with support for attending relevant industry conferences and training.
• This is a fully remote position, offering significant flexibility and work-life balance.
• You will be part of a highly professional and collaborative team, working on impactful projects that contribute to global health.
• Enjoy the convenience of working from your preferred location while contributing to a leading pharmaceutical company.
• Be part of a company that values innovation and regulatory excellence.