Senior Regulatory Affairs Leader Global Market Access

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

Benefits dieser Stelle

Generous base salary

Performance bonuses

Comprehensive benefits

Professional development

Zusammenfassung

Placements24 in Pretoria, Gauteng, seeks a Lead Regulatory Affairs Specialist to drive regulatory strategy across global markets. You will lead a team, oversee submissions, liaise with health authorities, ensure compliance, and guide product registrations from early development to post-approval.

The role requires a strong scientific background, 7+ years in regulatory affairs, and proven leadership. Competitive package and extensive development opportunities are offered.

Qualifikationen

• Master's degree or PhD in a scientific or related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with at least 2 years in a lead or supervisory role.

Aufgaben

• Develop and implement regulatory strategies for product development and lifecycle management in global markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities worldwide.
• Serve as the primary point of contact for regulatory agencies, addressing queries and managing submissions.
• Ensure that all company products and activities comply with current local and international regulatory requirements.
• Interpret regulatory guidelines and advise project teams on regulatory implications.
• Lead and mentor a team of regulatory professionals, overseeing performance and development.
• Conduct regulatory intelligence to stay informed about evolving regulations and advise on strategy.
• Collaborate with R&D, clinical, manufacturing, and legal teams to align regulatory strategies.
• Manage post-approval activities, including variations, renewals, and inspections.

Kenntnisse

Leadership

Strategic thinking

Analytical

Problem solving

Interpersonal communication

Regulatory submissions

Ausbildung

Master's degree or PhD in a scientific field

Jobbeschreibung

Placements24 in Pretoria, Gauteng, seeks a Lead Regulatory Affairs Specialist to drive regulatory strategy across global markets. You will lead a team, oversee submissions, liaise with health authorities, ensure compliance, and guide product registrations from early development to post-approval.

The role requires a strong scientific background, 7+ years in regulatory affairs, and proven leadership. Competitive package and extensive development opportunities are offered.