Senior Regulatory Affairs Manager - Api Development

Placements24; Gqeberha; Hybride; ZAR 1 000 000 - 1 800 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement contributions

Paid time off

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

Regulatory submissions

Communication

Project management

Analytical skills

Formation

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

Description du poste

About the Role

Our client, a dynamic and rapidly growing pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Manager to oversee regulatory strategies for Active Pharmaceutical Ingredient (API) development. This position is based in Port Elizabeth, Eastern Cape. You will be responsible for ensuring that all API development activities and submissions meet stringent global regulatory requirements. This role requires a deep understanding of regulatory landscapes for APIs and intermediates, and the ability to navigate complex compliance pathways. You will play a vital part in bringing innovative pharmaceutical products to market by ensuring seamless regulatory approvals.

Key Responsibilities

• Develop and implement regulatory strategies for API development projects, from early phase to commercialization.
• Prepare, review, and submit regulatory documentation for APIs, including Drug Master Files (DMFs) and CMC sections of marketing applications.
• Liaise with regulatory authorities (e.g., SAHPRA, FDA, EMA) on submission activities and respond to queries.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant quality standards for API manufacturing.
• Provide regulatory guidance and support to R&D, manufacturing, and quality assurance teams.
• Monitor changes in the regulatory environment and assess their impact on company strategies and operations.
• Conduct regulatory due diligence for potential partnerships and acquisitions.
• Train and mentor junior regulatory affairs staff.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related scientific discipline.
• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry, with a significant focus on API development and manufacturing.
• Strong knowledge of global regulatory requirements for APIs, including DMFs, ICH guidelines, and cGMP.
• Proven experience in preparing and submitting regulatory dossiers to major health authorities.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to manage multiple projects simultaneously and work effectively in a cross-functional team environment.
• Detail-oriented with strong analytical and problem-solving skills.
• Experience working with contract manufacturing organizations (CMOs) is an advantage.

Benefits

Our client offers a competitive salary and an attractive benefits package, including health insurance, retirement contributions, and paid time off. This hybrid role provides flexibility, combining remote work with in-office collaboration in Port Elizabeth, Eastern Cape. Opportunities for professional growth and development within a thriving pharmaceutical organization are abundant.