Regulatory Affairs Specialist

Placements24; United States; Hybrid; USD 55,000 - 79,000; Full time

Benefits offered by this job

Hybrid work model promoting flexibilty

Comprehensive health insurance

Retirement savings plan

International training opportunities

Generous leave policy

Job summary

Placements24 is seeking a Regulatory Affairs Specialist for our pharmaceutical client in South Africa. The role focuses on preparing, reviewing, and submitting regulatory dossiers to SAHPRA and other authorities, ensuring compliance across global markets.

The position blends on-site strategic work with remote analysis, supporting product lifecycle and labeling accuracy. The ideal candidate has a pharmacy or life sciences background, 5+ years in regulatory affairs, and strong knowledge of ICH and

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• Master's degree or relevant professional qualification is advantageous.
• Minimum of 5 years in regulatory affairs within pharma.
• Experience preparing and submitting dossiers to SAHPRA and other authorities.
• Strong knowledge of ICH and GxP guidelines.
• Excellent written and verbal communication, detail-oriented.

Responsibilities

• Prepare, compile, and submit regulatory documentation (CTD) for new drugs, variations and renewals.
• Ensure ongoing regulatory compliance with SAHPRA, FDA, EMA etc.
• Review labeling and promotional materials for regulatory fit.
• Liaise with health authorities and manage submission processes.
• Maintain up-to-date regulatory knowledge and provide guidance to the business.
• Conduct regulatory intelligence to identify risks and opportunities.
• Support lifecycle management including post-approval changes.
• Collaborate with R&D, QA, and Marketing to deliver regulatory guidance.
• Manage regulatory databases and record-keeping.
• Contribute to regulatory strategy development and implementation.

Skills

Regulatory affairs

Dossier submission

Regulatory guidance

Regulatory intelligence

Communication skills

Independent worker

Education

Bachelor's degree in Pharmacy, Life Sciences, Chemistry

Master's degree advantageous

Tools

Regulatory information management systems

Job description

About the Role

Our client, a reputable pharmaceutical company, is seeking a diligent and experienced Regulatory Affairs Specialist to join their team in **Klerksdorp, North West**. This role is crucial for ensuring that our client's pharmaceutical products comply with all relevant national and international regulations, facilitating smooth market access and product approvals. The specialist will be responsible for preparing, reviewing, and submitting regulatory dossiers, maintaining regulatory compliance, and liaising with health authorities. This hybrid position allows for a balance between on-site strategic planning and necessary laboratory/office-based work, and remote preparation and analysis, fostering productivity and work-life balance. We are committed to high standards of safety and efficacy, and this role is central to upholding those principles.

Key Responsibilities

• Prepare, compile, and submit regulatory documentation (e.g., CTD format) for new drug applications, variations, and renewals to health authorities.
• Ensure ongoing compliance with all applicable regulatory requirements and guidelines (e.g., SAHPRA, FDA, EMA).
• Review and approve labeling, promotional materials, and product information to ensure regulatory compliance.
• Liaise directly with health authorities, responding to queries and managing the regulatory submission process.
• Maintain up-to-date knowledge of evolving regulatory landscapes and advise the business accordingly.
• Conduct regulatory intelligence activities to identify potential risks and opportunities.
• Support regulatory aspects of product lifecycle management, including post-approval changes.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to provide regulatory guidance.
• Manage regulatory databases and ensure accurate record-keeping.
• Contribute to the development and implementation of regulatory strategies.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• A Master's degree or relevant professional qualification is advantageous.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting regulatory dossiers to SAHPRA and other international health authorities.
• Strong understanding of pharmaceutical regulatory guidelines (ICH, GxP).
• Excellent knowledge of the drug development and approval process.
• Proficiency in regulatory information management systems and software.
• Exceptional written and verbal communication skills, with strong attention to detail.
• Ability to work independently and manage multiple projects in a dynamic environment.
• Strong negotiation and interpersonal skills.
• Must be legally authorized to work in **South Africa**.

Benefits

• Competitive salary package.
• Comprehensive health insurance coverage.
• Retirement savings plan.
• Opportunities for professional growth and international training.
• Hybrid work model promoting flexibility.
• Generous annual leave.
• A collaborative and supportive company culture.
• Potential for career advancement in a growing field.