Hybrid Senior Regulatory Strategy Lead – SAHPRA

Placements24; Stellenbosch; Hybrid; ZAR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

Executive salary and bonus

Comprehensive health and lifeinsurance

Retirement benefits

Generous annual leave

Professional development opportunities

Hybrid work arrangement

Job summary

Placements24, on behalf of a leading pharmaceutical company, seeks a Senior Regulatory Affairs Manager to lead regulatory strategy and submissions for SA markets from Stellenbosch, Western Cape. The role blends home-office work with essential on-site collaboration.

You will manage SAHPRA dossiers, ensure GMP/GCP/GLP compliance, mentor a regulatory team and coordinate with R&D, manufacturing and marketing to support product registrations and lifecycle management.

Qualifications

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology or related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA regulations and submission requirements, as well as international regulatory frameworks (e.g., FDA, EMA).
• Proven track record of successful regulatory submissions and approvals.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Strong leadership and team management capabilities.
• Exceptional written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple projects simultaneously.

Responsibilities

• Develop regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers to health authorities in South Africa and other target markets.
• Ensure ongoing compliance with GMP, GCP, GLP.
• Act as the primary point of contact with regulatory agencies, responding to queries.
• Monitor changes in the regulatory landscape and assess their impact on products and operations.
• Provide regulatory guidance and support to R&D, manufacturing, marketing, and other departments.
• Manage regulatory aspects of product recalls, variations, and annual reports.
• Lead and mentor a team of regulatory affairs professionals.

Skills

Regulatory strategy

Team leadership

Regulatory submissions

SAHPRA knowledge

Regulatory information management

Education

Master's or PhD in Pharmacy, Chemistry, Biology

Tools

Regulatory information management systems

FDA/EMA frameworks

Job description

Placements24, on behalf of a leading pharmaceutical company, seeks a Senior Regulatory Affairs Manager to lead regulatory strategy and submissions for SA markets from Stellenbosch, Western Cape. The role blends home-office work with essential on-site collaboration.

You will manage SAHPRA dossiers, ensure GMP/GCP/GLP compliance, mentor a regulatory team and coordinate with R&D, manufacturing and marketing to support product registrations and lifecycle management.