Regulatory Affairs Manager

Placements24; Durban; Hybrid; ZAR 1.200.000 - 1.800.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Executive health insurance

Pension plan

Generous leave

Professional development

Relocation assistance

Global exposure

Collaborative culture

Zusammenfassung

Placements24 in Durban, KwaZulu-Natal, seeks an experienced Regulatory Affairs Manager to lead regulatory operations. You will design global/regional strategies, oversee submissions, ensure compliance, and act as the primary liaison with health authorities.

The role requires strong leadership, deep knowledge of SA and international regulations, and the ability to mentor a team while guiding cross-functional partners in R&D, manufacturing, and marketing.

Qualifikationen

• Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
• 7+ years of progressive regulatory affairs experience in the pharmaceutical industry.
• Proven success in managing complex regulatory submissions and timely approvals.
• In-depth knowledge of regulatory requirements in key markets including South Africa.
• Strong understanding of drug development, manufacturing processes, and quality assurance.
• Excellent leadership, strategic thinking, and problem-solving skills.
• Exceptional communication, negotiation, and interpersonal abilities.
• Proven ability to manage and motivate a team.
• Experience with regulatory information management systems.

Aufgaben

• Develop and implement global and regional regulatory strategies for product registration and lifecycle management.
• Lead and manage regulatory submissions (e.g., NDAs, MAAs, variations) to health authorities in various markets.
• Ensure ongoing compliance with all applicable national and international regulations and guidelines.
• Act as the primary point of contact with regulatory agencies, managing communications and inquiries.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, marketing, and clinical affairs.
• Review and approve promotional materials and product labeling to ensure regulatory compliance.
• Monitor changes in the regulatory landscape and assess their impact on the company's product portfolio.
• Manage and mentor a team of regulatory affairs professionals, fostering their growth and development.
• Oversee the regulatory aspects of post-marketing surveillance and lifecycle management activities.
• Conduct regulatory intelligence activities to identify potential risks and opportunities.

Kenntnisse

Regulatory strategy

Leadership

Regulatory submissions

Stakeholder management

Regulatory intelligence

Cross-functional collaboration

Team mentoring

Quality systems

Ausbildung

Master's or Ph.D. in Pharmacy/ Chemistry/ Biology

Tools

Regulatory information management

Jobbeschreibung

About the Role

Our client, a prominent and innovative force in the pharmaceutical industry , is seeking an experienced and strategic Regulatory Affairs Manager to lead their regulatory operations in Durban, KwaZulu-Natal . This senior position will be responsible for overseeing all aspects of regulatory compliance, ensuring that new and existing pharmaceutical products meet the stringent requirements of regulatory authorities. You will play a critical role in shaping regulatory strategies, managing submissions, and fostering positive relationships with key regulatory bodies. The successful candidate will possess extensive knowledge of regulatory frameworks, a keen understanding of the product lifecycle, and strong leadership capabilities. This is an exceptional opportunity for a seasoned regulatory professional to drive success in a vibrant coastal city, contributing to the accessibility of vital medicines.

Key Responsibilities

• Develop and implement global and regional regulatory strategies for product registration and lifecycle management.
• Lead and manage regulatory submissions (e.g., NDAs, MAAs, variations) to health authorities in various markets.
• Ensure ongoing compliance with all applicable national and international regulations and guidelines.
• Act as the primary point of contact with regulatory agencies, managing communications and addressing inquiries.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, marketing, and clinical affairs.
• Review and approve promotional materials and product labeling to ensure regulatory compliance.
• Monitor changes in the regulatory landscape and assess their impact on the company's product portfolio.
• Manage and mentor a team of regulatory affairs professionals, fostering their growth and development.
• Oversee the regulatory aspects of post-marketing surveillance and lifecycle management activities.
• Conduct regulatory intelligence activities to identify potential risks and opportunities.

Requirements

• Master's or Ph.D. degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 7 years of progressive experience in regulatory affairs within the pharmaceutical industry .
• Demonstrated success in managing complex regulatory submissions and achieving timely approvals.
• In-depth knowledge of regulatory requirements and guidelines in key markets, including South Africa.
• Strong understanding of drug development, manufacturing processes, and quality assurance.
• Excellent leadership, strategic thinking, and problem-solving skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Proven ability to manage and motivate a team.
• Experience with regulatory information management systems.
• Must be able to work effectively in a hybrid work model based in Durban, KwaZulu-Natal .

Benefits

• Highly competitive salary and performance-based bonuses.
• Comprehensive executive health insurance package.
• Generous retirement savings plan with employer contributions.
• Substantial annual leave and corporate holiday entitlements.
• Significant investment in professional development, including conferences and training.
• Relocation assistance available for qualified candidates.
• Opportunity to work with a leading global pharmaceutical company.
• Dynamic and collaborative work environment.