Senior Regulatory Affairs Specialist

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation

Medical benefits

Retirement plan

Job summary

Placements24 in Port Elizabeth, Eastern Cape, SA, is seeking a highly experienced Senior Regulatory Affairs Specialist to ensure compliance with SAHPRA and lead regulatory filings for new registrations and variations. You will manage submissions, monitor regulatory changes, liaise with health authorities, and support lifecycle management in a hybrid role balancing office collaboration with flexibility.

Join a dynamic pharmaceutical team focused on bringing innovative medicines to patients while

Qualifications

• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of SAHPRA regulations and submission processes.
• Experience preparing and submitting registration dossiers (CTD).
• Strong communication and interpersonal skills.

Responsibilities

• Prepare, compile, and submit regulatory documentation for new product registrations and variations.
• Ensure compliance with current SAHPRA guidelines and other relevant regulations.
• Manage and track regulatory submissions and approvals.
• Respond to queries from regulatory agencies and provide necessary documentation.
• Maintain product registration databases and regulatory filing systems.
• Monitor regulatory changes and assess their impact on company products and processes.
• Provide regulatory support to other departments, including marketing, R&D, and quality assurance.
• Assist in the preparation of responses to deficiencies and requests from health authorities.
• Contribute to the development and implementation of regulatory strategies.

Skills

Analytical skills

Problem-solving

Communication skills

Interpersonal skills

Project mindset

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Tools

Regulatory information management systems

Job description

About the Role

Our client, a dynamic and growing pharmaceutical company, is looking for a highly experienced Senior Regulatory Affairs Specialist to join their team in **Port Elizabeth, Eastern Cape, ZA**. This role is integral to ensuring that our client's products meet all relevant regulatory requirements for marketing and sale. You will be responsible for preparing and submitting regulatory filings, managing post-approval changes, and liaising with health authorities. The ideal candidate will possess a strong understanding of the South African regulatory landscape and a proven track record in regulatory affairs within the pharmaceutical sector. This position offers a fantastic opportunity to contribute to a company committed to bringing innovative medicines to patients while working in a hybrid environment that balances office collaboration with personal flexibility. We are seeking a detail-oriented and proactive individual to uphold our client's compliance standards.

Key Responsibilities

• Prepare, compile, and submit regulatory documentation for new product registrations and variations.
• Ensure compliance with current South African Health Products Regulatory Authority (SAHPRA) guidelines and other relevant regulations.
• Manage and track regulatory submissions and approvals.
• Respond to queries from regulatory agencies and provide necessary documentation.
• Maintain product registration databases and regulatory filing systems.
• Monitor regulatory changes and assess their impact on company products and processes.
• Provide regulatory support to other departments, including marketing, R&D, and quality assurance.
• Assist in the preparation of responses to deficiencies and requests from health authorities.
• Contribute to the development and implementation of regulatory strategies.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of SAHPRA regulations and submission processes.
• Proven experience in preparing and submitting registration dossiers (e.g., CTD format).
• Familiarity with post-approval regulatory activities and lifecycle management.
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Effective communication and interpersonal skills, with the ability to build relationships with regulatory bodies.
• Proficiency in Microsoft Office Suite and regulatory information management systems.
• Ability to manage multiple projects and prioritize effectively in a fast-paced environment.

Benefits

• Competitive salary package reflecting your expertise and experience.
• Hybrid work model offering a blend of office and remote work.
• Comprehensive medical and retirement benefits.
• Opportunities for professional growth and development.
• A supportive and collaborative team environment.
• Company-provided resources and support.