Senior Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Richards Bay; Hybrid; ZAR 900,000 - 1,700,000; Full time

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist based in Richards Bay, KwaZulu-Natal, to lead global regulatory strategies and lifecycle management. The role involves preparing dossiers (CTD, IND, NDA, MAA) for authorities worldwide and coordinating with R&D, QA, manufacturing, and legal teams to ensure compliance and timely approvals.

You will monitor regulatory trends, advise on regional requirements, and contribute to SOPs, post-approval activities, and variations.

Qualifications

• Bachelor's degree in life science, pharmacy, or related field.
• Master's or Ph.D. is a plus.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission requirements and guidelines (ICH, FDA, EMA, SAHPRA).
• Proven experience in preparing and submitting regulatory dossiers.
• Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
• Excellent written and verbal communication skills.
• Strong analytical, problem-solving, and strategic thinking abilities.
• Demonstrated ability to work independently and collaboratively in a fast-paced environment.
• Experience in managing multiple projects and prioritizing tasks effectively.
• Proficiency in regulatory information management systems is advantageous.

Responsibilities

• Develop and implement global regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities worldwide.
• Liaise with regulatory agencies, respond to queries, and manage the review process to ensure timely approvals.
• Interpret and advise on complex regulatory requirements and guidelines across different regions.
• Assess the regulatory impact of proposed product changes, manufacturing updates, and labeling modifications.
• Collaborate with R&D, clinical, manufacturing, and legal teams to ensure alignment on regulatory submissions and strategies.
• Monitor regulatory intelligence and provide updates on emerging trends and changes in pharmaceutical regulations.
• Contribute to the development and maintenance of regulatory standard operating procedures (SOPs).
• Manage regulatory documentation and ensure compliance with filing commitments.
• Support post-approval regulatory activities, including annual reports and variations.

Skills

Regulatory affairs

Regulatory submissions

Analytical thinking

Problem solving

Strategic thinking

Communication skills

Multi-project management

Education

Bachelor's degree in life sciences/Pharma

Master's or Ph.D. preferred

Tools

Regulatory information management systems

Job description

About the Role

Our client, a distinguished leader in the global pharmaceutical landscape, is actively seeking an accomplished Senior Regulatory Affairs Specialist to join their esteemed team. This pivotal role, based in Richards Bay, KwaZulu-Natal, will be instrumental in guiding the strategic development and execution of regulatory submission plans for new and existing pharmaceutical products across various international markets. The ideal candidate will possess a profound understanding of global regulatory requirements and a proven track record of successfully navigating complex submission processes. This is a unique opportunity to influence product lifecycle management and contribute significantly to market access for innovative therapies. You will collaborate closely with cross-functional teams, including R&D, clinical operations, quality assurance, and marketing, to ensure regulatory compliance and achieve strategic business objectives. We are seeking a proactive, analytical, and highly organized professional with exceptional communication skills and a strong ability to influence stakeholders. This position demands a strategic thinker capable of anticipating regulatory trends and challenges, ensuring our client remains at the forefront of pharmaceutical innovation.

Key Responsibilities

• Develop and implement global regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities worldwide.
• Liaise with regulatory agencies, respond to queries, and manage the review process to ensure timely approvals.
• Interpret and advise on complex regulatory requirements and guidelines across different regions.
• Assess the regulatory impact of proposed product changes, manufacturing updates, and labeling modifications.
• Collaborate with R&D, clinical, manufacturing, and legal teams to ensure alignment on regulatory submissions and strategies.
• Monitor regulatory intelligence and provide updates on emerging trends and changes in pharmaceutical regulations.
• Contribute to the development and maintenance of regulatory standard operating procedures (SOPs).
• Manage regulatory documentation and ensure compliance with filing commitments.
• Support post-approval regulatory activities, including annual reports and variations.

Requirements

• Bachelor's degree in a life science, pharmacy, or related field.
• Master's or Ph.D. is a plus.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA, SAHPRA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly.
• Strong analytical, problem-solving, and strategic thinking abilities.
• Demonstrated ability to work independently and collaboratively in a fast-paced environment.
• Experience in managing multiple projects and prioritizing tasks effectively.
• Proficiency in regulatory information management systems is advantageous.

Benefits

• Competitive remuneration package including salary and performance-based incentives.
• Comprehensive health, wellness, and retirement benefits.
• Significant opportunities for professional growth and international exposure.
• Flexible working arrangements to support work-life balance.
• Access to cutting-edge regulatory intelligence and resources.
• A highly collaborative and supportive international team environment.
• Contribution to bringing innovative medicines to patients worldwide.
• Generous paid time off and professional development budget.
• Company-sponsored training and conference attendance.
• Modern office facilities with amenities.