Senior Pharmaceutical Regulatory Affairs Manager

Placements24; Polokwane; Hybrid; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, and vision insurance

Retirement fund

Paid time off and professional dev

Job summary

Placements24 seeks a Senior Pharmaceutical Regulatory Affairs Manager to lead global regulatory strategies from Polokwane, ensuring timely submissions to SAHPRA, EMA, and FDA. You will manage a team of regulatory professionals and liaise with authorities to maintain lifecycle compliance.

The role requires extensive knowledge of international regulations, strong leadership, and strategic planning to drive innovative medicines to market.

Qualifications

• Advanced degree in Pharmacy, Life Sciences, or related field.
• 10+ years in pharmaceutical regulatory affairs with management experience.
• Proven ability to prepare/submission dossiers (CTD/eCTD).

Responsibilities

• Develop global regulatory strategies for NDAs/MAAs and post-approval changes.
• Lead regulatory submissions to authorities worldwide with accuracy and compliance.
• Mentor and manage a team of regulatory professionals.
• Serve as primary liaison with regulatory agencies and respond to inquiries.
• Monitor evolving regulatory guidelines and advise on impact.
• Review promotional materials and labeling for compliance.
• Collaborate with R&D, clinical ops, manufacturing, and legal to support regulatory goals.
• Oversee pharmacovigilance and lifecycle management.

Skills

Regulatory strategy

Team leadership

Regulatory submissions

Stakeholder communication

Project management

Education

Master's or Ph.D. in Pharmacy/Life Sciences

Tools

CTD/eCTD preparation

Job description

About the Role Our client, a distinguished international pharmaceutical company, is seeking a highly skilled and strategic Senior Pharmaceutical Regulatory Affairs Manager to lead their regulatory operations from Polokwane, Limpopo . This pivotal role is responsible for overseeing the development and execution of regulatory strategies for a diverse portfolio of pharmaceutical products, ensuring timely submissions and approvals in key global markets. The ideal candidate will possess extensive knowledge of global regulatory landscapes, including South African (SAHPRA), European (EMA), and US (FDA) requirements. You will manage a team of regulatory professionals, foster strong relationships with health authorities, and ensure compliance throughout the product lifecycle. This is an exceptional opportunity to shape the regulatory pathway of innovative medicines and contribute to a company renowned for its commitment to excellence, right here in Polokwane .

Key Responsibilities

• Develop and implement global regulatory strategies for new drug applications (NDAs), marketing authorization applications (MAAs), and post-approval changes.
• Lead regulatory submissions to health authorities worldwide, ensuring accuracy, completeness, and compliance with all applicable guidelines.
• Manage and mentor a team of regulatory affairs professionals, fostering their professional development.
• Serve as the primary point of contact with regulatory agencies, responding to queries and facilitating communications.
• Monitor and interpret evolving regulatory guidelines and advise internal stakeholders on their impact.
• Review and approve promotional materials and labeling to ensure regulatory compliance.
• Collaborate cross-functionally with R&D, clinical operations, manufacturing, and legal departments to support regulatory objectives.
• Oversee regulatory compliance activities, including pharmacovigilance and lifecycle management.

Requirements

• Advanced degree (Master's or Ph.D.) in Pharmacy, Life Sciences, or a related field.
• Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs, with a significant portion in a management role.
• Proven expertise in preparing and submitting regulatory dossiers (e.g., CTD, eCTD).
• Deep understanding of global regulatory requirements, particularly SAHPRA, FDA, and EMA regulations.
• Demonstrated success in obtaining marketing authorizations for pharmaceutical products.
• Strong leadership, communication, negotiation, and strategic planning skills.
• Ability to manage complex projects and cross-functional teams effectively.
• Excellent written and verbal communication skills, with a keen eye for detail.

Benefits

• Our client offers a highly competitive remuneration package, including a substantial base salary and performance-based incentives.
• We provide comprehensive medical, dental, and vision insurance plans, a robust retirement fund, and generous paid time off.
• Opportunities for continuous learning and career advancement are abundant, including funding for professional development and conference attendance.
• You will work in a stimulating environment with access to cutting-edge industry knowledge and resources.
• This position is based in Polokwane, Limpopo , and offers the chance to play a key role in bringing life-changing medicines to patients globally.