Senior Regulatory Affairs Manager (Pharmaceutical)

Placements24; Sandton; On-site; ZAR 1,500,000 - 2,300,000; Full time

Benefits offered by this job

Executive salary

Healthcare benefits

Retirement plan

International travel

Professional development

Job summary

Placements24 in Sandton, Gauteng, is seeking a Senior Regulatory Affairs Manager to lead regulatory operations for a global pharmaceutical portfolio. Based in Sandton, you will shape regulatory strategy, oversee dossier preparation (CTD, ANDA, NDA), and ensure timely approvals with SAHPRA, FDA, EMA and other authorities.

You will manage a team, align R&D, manufacturing, and marketing on regulatory requirements, monitor landscape changes, and drive compliance across the product lifecycle.

Qualifications

• Advanced degree in a life sciences field (Pharmacy, Chemistry, Biology) is required.
• Proven track record in global regulatory strategies and submissions.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Develop and implement regulatory strategies for new and existing products.
• Lead preparation, compilation, and submission of regulatory dossiers (CTD, ANDA, NDA) to global authorities.
• Serve as primary contact for regulatory agencies and manage communications.
• Ensure compliance with FDA, EMA, SAHPRA, and other regulations.
• Monitor regulatory landscape changes affecting products and strategies.
• Collaborate with R&D, clinical operations, manufacturing, and marketing teams.
• Provide regulatory guidance throughout the product lifecycle.
• Oversee post-approval activities (supplements, variations, annual reports).
• Mentor and manage a team of regulatory professionals.
• Contribute to development of regulatory policies and procedures.

Skills

Regulatory strategy

Leadership

Stakeholder communication

Team management

Education

Master's or PhD in Pharmacy, Chemistry, Biology

Job description

About the Role

Our client, a globally recognized pharmaceutical entity, is seeking an experienced and strategic Senior Regulatory Affairs Manager to lead their regulatory operations based in Sandton, Gauteng . This high-impact role requires a deep understanding of global regulatory strategies, submission processes, and compliance requirements for pharmaceutical products. The Senior Regulatory Affairs Manager will be responsible for overseeing the preparation and submission of regulatory dossiers to health authorities worldwide, ensuring timely approvals and maintaining compliance throughout the product lifecycle. This position demands exceptional leadership skills, strategic thinking, and the ability to navigate complex regulatory landscapes effectively. The ideal candidate will have a proven track record in successfully managing regulatory affairs for a diverse portfolio of pharmaceutical products. Join our client's committed team in Sandton, Gauteng and play a crucial role in bringing vital medicines to patients across the globe.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for new and existing pharmaceutical products.
• Lead the preparation, compilation, and submission of regulatory dossiers (e.g., CTD, ANDA, NDA) to global health authorities.
• Serve as the primary point of contact for regulatory agencies, managing communications and responses.
• Ensure all regulatory activities and submissions are in compliance with applicable regulations (FDA, EMA, SAHPRA, etc.) and guidelines.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Collaborate closely with R&D, clinical operations, manufacturing, and marketing teams to ensure alignment on regulatory requirements.
• Provide expert regulatory guidance and support throughout the product development lifecycle.
• Oversee post-approval regulatory activities, including supplements, variations, and annual reports.
• Manage and mentor a team of regulatory affairs professionals.
• Contribute to the development of company policies and procedures related to regulatory affairs.

Requirements

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 8-10 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in developing and executing global regulatory strategies.
• Extensive knowledge of regulatory submission requirements in key markets (US, EU, South Africa, etc.).
• Demonstrated success in preparing and filing major regulatory submissions.
• Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
• Exceptional communication, negotiation, and interpersonal skills.
• Proven leadership and team management capabilities.
• Ability to analyze complex regulatory issues and formulate effective solutions.
• Experience in therapeutic areas relevant to the company's portfolio is an advantage.

Benefits

Our client offers a competitive executive salary, performance-based bonuses, comprehensive healthcare benefits, a robust retirement plan, and opportunities for international travel and professional development. You will be working in a dynamic and innovative environment at our modern facility in Sandton, Gauteng , with the chance to significantly influence regulatory pathways for groundbreaking therapies. We provide a culture that encourages strategic thinking, collaboration, and career advancement within a leading global pharmaceutical organization.