Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Stellenbosch; On-site; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Retirement fund and benefits

Professional development opportunities

Collaborative compliance-focused team

Job summary

Placements24 seeks a Regulatory Affairs Specialist in Stellenbosch to ensure pharmaceutical products comply with national and international regulations throughout development to post-market. You will prepare regulatory documentation, liaise with health authorities, and monitor evolving regulations to support market access and ongoing compliance.

The role requires a Bachelor’s degree in a relevant field and a minimum of 4 years in regulatory affairs, with strong SAHPRA experience and CTD dossier

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related.
• Minimum 4 years in regulatory affairs within pharma.
• Strong understanding of South African and international regulations.

Responsibilities

• Prepare, review, and submit regulatory documentation to SAHPRA and other authorities.
• Ensure submissions comply with GMP/GCP and applicable regs.
• Serve as main regulatory contact with agencies; respond to queries.
• Monitor regulatory changes and assess impact on products and ops.
• Develop regulatory strategies to support development and lifecycle management.
• Maintain regulatory databases and archives with accurate documentation.

Skills

Regulatory submissions

GMP/GCP knowledge

Stakeholder communication

Regulatory strategy

Education

Bachelor's in Pharmacy/ Chemistry/ Life Sciences

Tools

CTD format

Job description

About the Role

Our client is seeking a sharp and knowledgeable Regulatory Affairs Specialist to join their team in Stellenbosch . This role is integral to ensuring that our client's pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle, from development to post-market surveillance. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This is an excellent opportunity for a dedicated professional to contribute to the successful market access and continued compliance of vital pharmaceutical products within the dynamic Western Cape market.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications, variations, and renewals to health authorities such as the SAHPRA.
• Ensure all regulatory submissions and activities are compliant with current Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other applicable regulations.
• Serve as a key contact for regulatory agencies, responding to queries and facilitating communication.
• Monitor and interpret changes in the regulatory environment, assessing their impact on the company's products and operations.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Maintain regulatory databases and archives, ensuring all documentation is accurate, organized, and readily accessible.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
• Strong understanding of pharmaceutical regulations in South Africa and key international markets.
• Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to negotiate effectively.

Benefits

• Competitive salary and annual bonus potential.
• Comprehensive health, dental, and vision insurance.
• Retirement fund and other employee benefits.
• Opportunities for professional development and continued education in regulatory affairs.
• A collaborative work environment focused on compliance and innovation in Stellenbosch .