Regulatory Affairs Specialist - Pharmaceuticals

Placements24; George; Hybrid; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Hybrid work model

Health insurance

Retirement benefits

Generous annual leave

Wellness programs

Job summary

Placements24 is recruiting a Regulatory Affairs Specialist for our George, Western Cape site to ensure products meet SAHPRA and international standards. You will manage submissions, maintain compliance, and monitor regulatory changes, collaborating with R&D, manufacturing and marketing.

Candidates with 4+ years in regulatory affairs, a relevant degree, and strong communication skills will fit. The role offers a hybrid work model, competitive remuneration, health insurance, retirement benefits,

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Law, or a related field.
• Proven experience (at least 4 years) in pharmaceutical regulatory affairs, with a strong understanding of SAHPRA regulations.
• Experience in preparing and submitting regulatory documentation for various product types (e.g., generics, NCEs).
• Excellent understanding of the drug development lifecycle and pharmaceutical manufacturing processes.
• Strong analytical, organizational, and project management skills.
• Exceptional written and verbal communication skills.
• Proficiency in regulatory information management systems and databases.
• Ability to work effectively under pressure and meet tight deadlines.
• A proactive approach to identifying and mitigating regulatory risks.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for new drug applications (NDAs) and variations to existing marketing authorizations.
• Liaise with health authorities (e.g., SAHPRA) to respond to queries and facilitate the approval process.
• Monitor and interpret regulatory guidelines and legislation, assessing their impact on the company's products and operations.
• Ensure all product labelling, packaging, and promotional materials comply with regulatory requirements.
• Maintain up-to-date regulatory intelligence and provide strategic advice to internal stakeholders.
• Manage post-approval regulatory activities, including renewals, amendments, and compliance reporting.
• Develop and maintain effective relationships with regulatory bodies and industry associations.
• Contribute to the development of regulatory strategies for new product launches and market expansion.

Skills

Analytical skills

Organizational skills

Project management

Communication skills

Regulatory risk management

Education

Bachelor's degree in Pharmacy, Life Sciences, Law or related field

Master's degree advantageous

Tools

Regulatory information systems

Job description

About the Role

Our client, a respected player in the pharmaceutical manufacturing landscape, is actively recruiting a Regulatory Affairs Specialist for their **George, Western Cape** operations. This position is pivotal in ensuring that all pharmaceutical products meet stringent national and international regulatory standards before reaching the market. The successful candidate will be responsible for managing the regulatory submission process, maintaining compliance, and staying abreast of evolving legislative requirements. This role is ideal for a detail-oriented professional with a strong understanding of the pharmaceutical industry's regulatory framework. You will collaborate closely with R&D, manufacturing, and marketing teams to facilitate product approvals and lifecycle management. Joining our client means becoming part of a team dedicated to bringing safe and effective medicines to patients across South Africa and beyond. The **George, Western Cape** location offers a unique work-life balance opportunity.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new drug applications (NDAs) and variations to existing marketing authorizations.
• Liaise with health authorities (e.g., SAHPRA) to respond to queries and facilitate the approval process.
• Monitor and interpret regulatory guidelines and legislation, assessing their impact on the company's products and operations.
• Ensure all product labelling, packaging, and promotional materials comply with regulatory requirements.
• Maintain up-to-date regulatory intelligence and provide strategic advice to internal stakeholders.
• Manage post-approval regulatory activities, including renewals, amendments, and compliance reporting.
• Develop and maintain effective relationships with regulatory bodies and industry associations.
• Contribute to the development of regulatory strategies for new product launches and market expansion.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Law, or a related field. A Master's degree is advantageous.
• Proven experience (at least 4 years) in pharmaceutical regulatory affairs, with a strong understanding of SAHPRA regulations.
• Experience in preparing and submitting regulatory documentation for various product types (e.g., generics, NCEs).
• Excellent understanding of the drug development lifecycle and pharmaceutical manufacturing processes.
• Strong analytical, organizational, and project management skills.
• Exceptional written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
• Proficiency in regulatory information management systems and databases.
• Ability to work effectively under pressure and meet tight deadlines.
• A proactive approach to identifying and mitigating regulatory risks.

Benefits

This position comes with a competitive remuneration package, comprehensive health insurance, and retirement benefits. Our client supports professional development through continuous training and opportunities to attend industry conferences. The role offers the flexibility of a **Hybrid** work model, combining office-based collaboration in **George, Western Cape** with remote work. Employees also enjoy generous annual leave and access to wellness programs. This is an excellent opportunity to advance your career in regulatory affairs within a forward-thinking pharmaceutical company.