Global Regulatory Strategy Lead for Medicines

Placements24; Sandton; On-site; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Travel opportunities

Bonuses

Job summary

Placements24 in Sandton seeks a seasoned Senior Regulatory Affairs Manager to lead regulatory operations across global markets. You will shape strategies for product registrations and lifecycle management, and mentor a team to deliver compliant submissions on time.

You will liaise with health authorities, ensure regulatory compliance, and provide strategic input on development and manufacturing to accelerate patient access to medicines in a fast-paced pharma environment.

Qualifications

• Master's or PhD in Pharmacy, Law, Biological Sciences, or a related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with at least 3 in a management role.
• Proven success obtaining marketing authorizations in major global markets (FDA, EMA, SAHPRA).
• In-depth knowledge of regulatory requirements for drug development, manufacturing, and post-marketing activities.
• Strong leadership, strategic thinking, and negotiation skills.

Responsibilities

• Develop and implement global regulatory strategies for new product registrations and lifecycle management.
• Lead and mentor the regulatory affairs team, fostering professional development and high performance.
• Oversee the preparation, review, and submission of regulatory dossiers to health authorities worldwide.
• Ensure continuous compliance with national and international pharmaceutical regulations and guidelines.
• Serve as the primary point of contact for regulatory agencies, managing communications and inspections.
• Provide strategic regulatory input on product development, clinical trials, and manufacturing processes.

Skills

Regulatory strategy

Dossier submissions

Team leadership

Stakeholder management

Global markets experience

Education

Master's or PhD in Pharmacy, Law, Biological Sciences, or related field

Job description

Placements24 in Sandton seeks a seasoned Senior Regulatory Affairs Manager to lead regulatory operations across global markets. You will shape strategies for product registrations and lifecycle management, and mentor a team to deliver compliant submissions on time.

You will liaise with health authorities, ensure regulatory compliance, and provide strategic input on development and manufacturing to accelerate patient access to medicines in a fast-paced pharma environment.