Regulatory Affairs Specialist - Pharmaceutical Products

Placements24; Benoni; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Performance-based incentives

Training and conference attendance

Job summary

Placements24 is seeking a Regulatory Affairs Specialist for our Benoni, Gauteng team. You will ensure compliance of pharmaceutical products with SAHPRA and international requirements, prepare regulatory submissions, liaise with health authorities, and support cross-functional teams.

You will monitor evolving regulations, review labeling and promotional materials, and contribute to regulatory strategies for product lifecycle management.

Qualifications

• Bachelor's degree in a life sciences or legal field is required.
• 4+ years of regulatory affairs experience in pharma.
• Strong knowledge of SAHPRA and international guidelines (FDA/EMA/ICH).
• Experience in preparing regulatory submissions and labeling reviews.

Responsibilities

• Prepare regulatory dossiers (e.g., CTD) for registrations and variations.
• Liaise with SAHPRA, FDA, EMA and others as required.
• Review labeling, promotional materials for compliance.
• Monitor regulatory changes and assess impact on products and operations.
• Manage post-approval activities like annual reports and amendments.
• Provide regulatory guidance to cross-functional teams (R&D, manufacturing, marketing).
• Maintain regulatory databases and filing systems.
• Participate in inspections and audits.
• Contribute to regulatory strategies for product lifecycle management.

Skills

Regulatory knowledge

Attention to detail

Project management

Communication skills

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or Law

Tools

MS Office Suite

Regulatory information management systems

Job description

About the Role

Our client, a respected pharmaceutical company, is seeking a skilled and knowledgeable Regulatory Affairs Specialist to join their team in Benoni, Gauteng . This vital role involves ensuring that our client's pharmaceutical products comply with all national and international regulatory requirements for marketing and distribution. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulations. This is an excellent opportunity for a detail-oriented professional to make a significant contribution to regulatory compliance in the pharmaceutical sector within the Gauteng province. The Benoni office serves as a key hub for our client's regulatory operations in the region.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers (e.g., CTD format) for new product registrations and variations.
• Liaise directly with regulatory agencies such as SAHPRA, FDA, EMA, and others as required.
• Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
• Monitor changes in regulatory legislation and guidelines, assessing their impact on the company's products and operations.
• Manage post-approval regulatory activities, including annual reports and amendments.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Maintain regulatory databases and filing systems, ensuring accuracy and completeness.
• Participate in regulatory inspections and audits.
• Assess the regulatory feasibility of new product development projects.
• Contribute to the development of regulatory strategies for product lifecycle management.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, Law, or a related scientific or legal field.
• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
• Comprehensive understanding of South African regulatory requirements (SAHPRA) and international regulations (e.g., FDA, EMA, ICH guidelines).
• Proven experience in preparing and submitting marketing authorization applications.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to interpret complex regulatory information and apply it to practical situations.
• Strong analytical and problem-solving skills.
• Proficiency in regulatory information management systems and MS Office Suite.
• Ability to work independently and manage multiple projects simultaneously in a deadline-driven environment.
• Experience in life cycle management of pharmaceutical products is a plus.

Benefits

• Our client offers a competitive salary and a robust benefits package, including health insurance, retirement contributions, and performance-based incentives.
• Professional development opportunities, including training and conference attendance, are actively supported.
• Employees work in a collaborative and stimulating environment with opportunities for growth.
• Join our team in Benoni, Gauteng , and play a key role in bringing essential medicines to market.