Senior Regulatory Affairs Manager – API (Hybrid)

Placements24; Gqeberha; Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Paid time off

Job summary

Placements24 seeks a Senior Regulatory Affairs Manager to lead regulatory strategies for API development, ensure submissions meet global requirements, and mentor a regulatory team in Port Elizabeth. The role demands deep knowledge of API regulatory landscapes and strong teamwork across R&D, manufacturing and QA.

The ideal candidate has 7+ years in regulatory affairs within pharma, with API focus, and will interact with SAHPRA, FDA and EMA.

Qualifications

• Minimum 7 years regulatory affairs experience in pharma, with API focus.
• Strong knowledge of global API regulatory requirements (DMFs, ICH guidelines, and cGMP).
• Excellent communication, negotiation, and interpersonal skills.
• Experience with CMOs is advantageous.

Responsibilities

• Develop and implement regulatory strategies for API development from early phase to commercialization.
• Prepare, review, and submit regulatory documentation for APIs, including DMFs and CMC sections.
• Liaise with authorities (SAHPRA, FDA, EMA) on submissions and respond to queries.
• Ensure compliance with cGMP and related quality standards for API manufacturing.
• Provide regulatory guidance to R&D, manufacturing and QA teams.
• Monitor regulatory changes and assess impact on strategy and operations.
• Conduct regulatory due diligence for partnerships and acquisitions.
• Train and mentor junior staff.

Skills

Regulatory strategy

Regulatory submissions

Communication

Project management

Analytical skills

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Chemical Engineering or related scientific discipline

Job description

Placements24 seeks a Senior Regulatory Affairs Manager to lead regulatory strategies for API development, ensure submissions meet global requirements, and mentor a regulatory team in Port Elizabeth. The role demands deep knowledge of API regulatory landscapes and strong teamwork across R&D, manufacturing and QA.

The ideal candidate has 7+ years in regulatory affairs within pharma, with API focus, and will interact with SAHPRA, FDA and EMA.