Lead Regulatory Affairs Specialist

Placements24; Pretoria; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Generous base salary

Performance bonuses

Comprehensive benefits

Professional development

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Strategic thinking

Analytical

Problem solving

Interpersonal communication

Regulatory submissions

Education

Master's degree or PhD in a scientific field

Job description

About the Role

Our client, a prominent pharmaceutical organization, is seeking an accomplished Lead Regulatory Affairs Specialist to spearhead their regulatory strategies from their offices in Pretoria, Gauteng. This senior position demands a strategic thinker with a comprehensive understanding of global regulatory landscapes and submission processes. You will be responsible for guiding product registration, ensuring compliance, and managing interactions with health authorities. This role is critical for ensuring timely market access for our client’s innovative medicines. You will lead a team of regulatory professionals, fostering a culture of compliance and excellence. This is a significant opportunity for an experienced professional to make a substantial impact within a reputable company dedicated to advancing healthcare.

Key Responsibilities

• Develop and execute regulatory affairs strategies for product development and lifecycle management in various 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 complex regulatory guidelines and advise project teams on regulatory implications.
• Lead and mentor a team of regulatory affairs professionals, overseeing their performance and development.
• Conduct regulatory intelligence activities to stay informed about evolving regulations and advise on strategic adjustments.
• Collaborate with cross-functional teams, including R&D, clinical, manufacturing, and legal, to ensure alignment on regulatory strategies.
• Manage post-approval regulatory activities, including variations, renewals, and compliance monitoring.
• Participate in regulatory inspections and audits, ensuring readiness and compliance.

Requirements

• Master's degree or PhD in a scientific or related field (e.g., Pharmacy, Biology, Chemistry).
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with at least 2 years in a lead or supervisory role.
• Demonstrated success in managing regulatory submissions and achieving timely approvals in major markets (e.g., US, EU, South Africa).
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission requirements.
• Strong understanding of drug development processes, from early-stage research to post-marketing.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Exceptional leadership, team management, and interpersonal communication abilities.
• Proficiency in regulatory information management systems and electronic submission tools.
• Ability to effectively manage multiple complex projects and prioritize tasks in a dynamic environment.
• Commitment to maintaining the highest standards of regulatory compliance and ethical conduct in Pretoria, Gauteng.

Benefits

• generous base salary
• performance bonuses
• comprehensive benefits such as medical, dental, and vision coverage, life insurance, and a retirement savings plan
• extensive professional development opportunities, including training, workshops, and conference attendance