Senior Regulatory Affairs Manager

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

About the Role

Our client is seeking a seasoned and strategic Senior Regulatory Affairs Manager to lead their regulatory operations in Sandton . This pivotal role involves overseeing the development and execution of regulatory strategies for product approvals and lifecycle management across various global markets. You will guide a team of regulatory professionals, ensure compliance with all applicable regulations, and act as a key liaison with health authorities. This position demands strong leadership, comprehensive regulatory expertise, and a forward-thinking approach to navigating the complexities of the pharmaceutical industry, contributing to the company's success and patient access to critical medicines.

Key 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.

Requirements

• 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 years in a management role.
• Demonstrated success in obtaining marketing authorizations in major global markets (e.g., FDA, EMA, SAHPRA).
• In-depth knowledge of regulatory requirements for drug development, manufacturing, and post-marketing activities.
• Exceptional leadership, strategic thinking, and negotiation skills.
• Strong ability to interpret complex regulatory information and provide clear guidance.

Benefits

• Highly attractive annual salary and significant performance-based bonus structure.
• Comprehensive health, dental, and vision insurance plans.
• Generous pension scheme and long-term incentive opportunities.
• Opportunities for extensive professional development and international travel.
• Dynamic and collaborative work environment in a leading corporate hub.