Senior Regulatory Affairs Specialist (Pharmaceuticals)

Placements24; Bloemfontein; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Retirement fund

Performance-based bonuses

Training programs

Career development opportunities

Job summary

Placements24 in Bloemfontein, Free State, seeks an experienced Senior Regulatory Affairs Specialist to ensure compliance with SAHPRA and international regulations for development, registration and lifecycle management of pharmaceutical products. You will shape regulatory strategies, prepare submission dossiers, and liaise with health authorities while collaborating with R&D, QA, and commercial teams.

The role requires a strategic thinker with strong attention to detail, proven submission

Qualifications

• Master's degree or PhD in pharmacy, chemistry, biology or related field.
• Minimum of 6 years in pharmaceutical regulatory affairs.
• Proven track record of regulatory submissions and approvals.
• Expert knowledge of SAHPRA and major international markets (FDA, EMA).

Responsibilities

• Develop regulatory strategies for product registrations and lifecycle management.
• Prepare and submit CTD-style dossiers to authorities.
• Serve as primary liaison with regulatory agencies.
• Monitor evolving regulations and advise on impact.
• Guide labeling, advertising, and promotional materials for compliance.
• Support cross-functional teams with regulatory guidance.
• Manage variations, renewals, and annual reporting.

Skills

Regulatory strategy

CTD knowledge

Regulatory submissions

Cross-functional collaboration

Education

Master's degree

PhD

Tools

eCTD software

Regulatory databases

Job description

About the Role

Our client, a prominent and expanding pharmaceutical company, is actively seeking an experienced Senior Regulatory Affairs Specialist to join their dedicated team in Bloemfontein, Free State. This pivotal role is responsible for ensuring compliance with all national and international regulatory requirements for the development, registration, and lifecycle management of pharmaceutical products. The successful candidate will play a crucial role in shaping regulatory strategies, preparing submission dossiers, and liaising with health authorities. This position offers a challenging and rewarding opportunity to contribute to the accessibility of vital medicines. You will work closely with R&D, quality assurance, and commercial teams, providing expert regulatory guidance. We are looking for a strategic thinker with a deep understanding of the pharmaceutical regulatory landscape and a strong commitment to accuracy and compliance, operating within Bloemfontein. Our client values integrity, scientific rigor, and a proactive approach to regulatory challenges.

Key Responsibilities

• Develop and implement regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD format) to national and international health authorities.
• Serve as the primary point of contact with regulatory agencies, responding to queries and facilitating communication.
• Monitor and interpret evolving regulatory landscapes, guidelines, and legislation, assessing their impact on the company's products.
• Ensure compliance of product labeling, advertising, and promotional materials with regulatory requirements.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Manage post-approval regulatory activities, such as variations, renewals, and annual reporting.
• Conduct regulatory intelligence activities to identify opportunities and mitigate risks.
• Contribute to the development and maintenance of company regulatory policies and procedures.
• Participate in internal and external audits as regulatory subject matter expert.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in key markets.
• In-depth knowledge of regulatory requirements in South Africa (SAHPRA) and major international markets (e.g., FDA, EMA).
• Experience with Common Technical Document (CTD) format and regulatory submission software.
• Strong analytical, strategic thinking, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
• Proficiency in project management and cross-functional team collaboration.
• High level of attention to detail and commitment to regulatory compliance.
• Experience working within the pharmaceutical industry in Free State or similar regulated environments is a strong asset.
• Ability to work independently and manage multiple priorities effectively.

Benefits

Our client offers a competitive salary, a comprehensive benefits package including health insurance and a retirement fund, and performance-based bonuses. This role provides significant opportunities for professional development, including training programs and participation in industry conferences. You will work in a supportive and collaborative environment with a focus on innovation and career growth. The position is based in Bloemfontein, offering a balance between professional advancement and quality of life. Benefits also include generous paid time off and access to state-of-the-art resources. Our client is committed to fostering a diverse and inclusive workplace.