Regulatory Affairs Manager - Pharmaceutical Submissions

Placements24; Stellenbosch; On-site; ZAR 1,200,000 - 1,900,000; Full time

Benefits offered by this job

Executive salary

Benefits package

Private health insurance

Retirement fund

Performance-based incentives

Professional development

Leadership training

International regulatory conferences

Job summary

Placements24 seeks an experienced Regulatory Affairs Manager to lead global regulatory submissions from its Paarl-based offices. You will develop strategies for NDAs/MAAs and oversee CTD/eCTD dossiers, ensuring timely approvals across major markets.

Strong leadership and collaboration with R&D, manufacturing, and commercial teams are essential. The role requires 8+ years in regulatory affairs, deep knowledge of FDA/EMA/SAHPRA processes, and a track record of successful submissions.

Qualifications

• Master's or PhD in Pharmacy, Life Sciences, Chemistry, or related field.
• 8+ years in pharmaceutical regulatory affairs with global submissions.
• Strong knowledge of regulatory requirements and submission processes (FDA, EMA, SAHPRA).
• Excellent strategic thinking, problem solving, and project management.

Responsibilities

• Develop and implement global regulatory strategies for NDAs/MAAs.
• Lead preparation, review, and submission of regulatory dossiers (CTD, eCTD).
• Liaise with regulatory agencies, respond to queries, and facilitate meetings.
• Monitor regulatory landscape and provide strategic guidance to internal teams.
• Ensure compliance with regulations, guidelines, and company policies.
• Manage post-approval regulatory activities (supplements, variations, annual reports).
• Mentor and manage junior regulatory staff.

Skills

Strategic thinking

Leadership

Project management

Communication

Regulatory strategy

Education

Master's or PhD in Pharmacy

Tools

RIMS

eCTD publishing tools

Job description

About the Role

Our client, a rapidly growing pharmaceutical company, is seeking an experienced and strategic Regulatory Affairs Manager to lead their regulatory submission efforts. This key role, based in Paarl, Western Cape, is responsible for developing and executing regulatory strategies to ensure timely approval of new pharmaceutical products and lifecycle management of existing ones. The Manager will oversee the preparation, submission, and maintenance of regulatory dossiers to health authorities in various global markets, ensuring full compliance with all applicable regulations. This position offers a unique opportunity to shape the regulatory pathway for innovative medicines and contribute significantly to the company's global market access.

Key Responsibilities

• Develop and implement global regulatory strategies for new drug applications (NDAs) and marketing authorization applications (MAAs).
• Lead the preparation, review, and submission of regulatory dossiers (e.g., CTD, eCTD) to health authorities worldwide.
• Liaise directly with regulatory agencies, responding to queries and facilitating meetings.
• Monitor and interpret evolving regulatory landscapes, providing strategic guidance to internal teams.
• Ensure all regulatory activities comply with relevant regulations, guidelines (e.g., ICH), and company policies.
• Manage post-approval regulatory activities, including supplements, variations, and annual reports.
• Collaborate closely with R&D, clinical, manufacturing, and commercial teams to ensure regulatory requirements are met throughout the product lifecycle.
• Assess the regulatory implications of product changes and new development projects.
• Mentor and manage junior regulatory affairs staff.

Requirements

• Master's or PhD degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs, with a strong track record in successful global submissions.
• In-depth knowledge of regulatory requirements and submission processes in major markets (e.g., FDA, EMA, SAHPRA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent strategic thinking, problem-solving, and project management skills.
• Exceptional written and verbal communication skills, with the ability to negotiate effectively with health authorities.
• Strong leadership capabilities and the ability to build and maintain effective relationships with internal and external stakeholders.
• Proficiency in regulatory information management systems (RIMS) and eCTD publishing tools.
• Ability to work under pressure and manage multiple complex projects simultaneously.

Benefits

• competitive executive salary
• a comprehensive benefits package
• private health insurance
• a generous retirement fund
• potential for significant performance-based incentives
• professional development opportunities
• leadership training
• attendance at international regulatory affairs conferences

The role is based in the scenic and vibrant region of Paarl. Employees will enjoy a dynamic and intellectually stimulating work environment, fostering innovation and career growth. Join our client and play a critical role in bringing life-changing therapies to patients around the world.

We are committed to diversity and inclusion in our workforce.