Lead Regulatory Affairs Specialist

Placements24; Sandton; Hybrid; ZAR 1,400,000 - 2,300,000; Full time

Benefits offered by this job

Bonus

Long‑term incentives

Health benefits

Retirement plan

Career growth

Job summary

Placements24 seeks a Lead Regulatory Affairs Specialist to join our team in Sandton in a hybrid capacity. You will drive regulatory strategies for new and existing pharmaceutical products, ensuring compliance with FDA, EMA, SAHPRA and ICH guidelines.

A proactive, senior professional will lead cross-functional teams and manage lifecycle activities. The role requires extensive experience navigating complex regulatory pathways, preparing submission dossiers, and guiding post-approval activities.

Qualifications

• Master's or PhD in Pharmacy, Life Sciences, Chemistry, or related field.
• Excellent written and verbal communication; strong leadership and cross-functional collaboration.
• Strategic thinking and decision-making with regulatory expertise.

Responsibilities

• Develop and execute global regulatory strategies for product development, registration, and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD, IND, NDA, MAA) to health authorities worldwide.
• Lead submissions and interactions with regulators during inspections.
• Monitor evolving guidelines and advise on strategic regulatory implications.
• Manage post-approval activities, including variations, renewals, and annual reports.
• Mentor junior staff and collaborate with R&D, Clinical, Manufacturing, Marketing.

Job description

About the Role Our client, a prominent biopharmaceutical company, is actively searching for a Lead Regulatory Affairs Specialist to join their team in Sandton . This hybrid role offers a strategic balance between essential on-site collaboration for key decision-making and remote work for document preparation and analysis. You will be responsible for developing and executing regulatory strategies for new and existing pharmaceutical products, ensuring compliance with global health authority requirements. This role requires a seasoned regulatory professional with extensive experience in navigating complex regulatory pathways, preparing submission dossiers, and managing post-approval activities. The ideal candidate is a proactive problem-solver with strong leadership capabilities and a deep understanding of the pharmaceutical industry landscape. You will play a critical role in bringing innovative therapies to market and ensuring their continued compliance.

Key Responsibilities

• Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
• 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 during submissions and inspections.
• Monitor and interpret evolving regulatory guidelines and advise the organization on strategic implications.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Collaborate with cross-functional teams (R&D, Clinical, Manufacturing, Marketing) to ensure regulatory compliance throughout the product lifecycle.
• Assess the regulatory implications of manufacturing changes and product line extensions.
• Lead regulatory submission planning and execution, ensuring timely and high-quality submissions.
• Provide regulatory input and guidance on product labeling and promotional materials.
• Mentor junior regulatory affairs staff and contribute to team development.

Requirements

• Master's degree or Ph.D. in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 7 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Proven track record of successfully managing regulatory submissions and obtaining product approvals globally.
• In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, SAHPRA) and ICH guidelines.
• Strong strategic thinking, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills, with strong negotiation abilities.
• Demonstrated leadership capabilities and experience managing cross-functional teams.
• Ability to work effectively in a hybrid environment, managing both on-site and remote responsibilities.
• Proficiency in regulatory information management systems and document authoring tools.
• High ethical standards and integrity.

Benefits

Our client offers a competitive executive compensation package, including a generous base salary, bonus, and long-term incentives. Comprehensive health and wellness benefits, including medical, dental, vision, and a robust retirement plan, are provided. Significant opportunities for professional growth, leadership development, and career advancement within a globally recognized organization are available. This hybrid role provides flexibility while ensuring key strategic contributions in Sandton . Be at the forefront of regulatory strategy in the pharmaceutical industry.