Regulatory Affairs Scientist

Biovac was founded in 2003 to revive and restore South Africa’s vaccine manufacturing capabilities. We are an African based manufacturer contributing towards filling the gap that exists in the lack of African vaccine manufacturing capability.

Job Purpose: This role is responsible for providing scientific and regulatory support, which includes supporting regulatory submissions, quality assurance, compliance activities, and participating in cross-functional regulatory interactions. All activities are carried out in alignment with the requirements of the South African Health Products Regulatory Authority (SAHPRA), World Health Organization Prequalification (WHO PQ), and other applicable international regulatory standards.

The role supports the authoring, compilation, ongoing maintenance, and lifecycle management of regulatory dossiers for vaccine biologicals and sterile products. The role is integral to ensuring compliance with national, regional, and international regulatory requirements, and contributes to timely product registrations, variations, renewals, and regulatory compliance throughout the product’s lifecycle.

There is a particular emphasis on meeting the requirements of SAHPRA, WHO Prequalification, and reliance-based pathways that are relevant to vaccines and biological products. Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws. Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Requirements:

• Bachelor’s degree in Pharmacy, BSc Honours in Life Sciences, Biotechnology, Chemistry, or a related scientific discipline.

Experience & industry knowledge: Required:

• Minimum 3 – 5 years’ experience in Regulatory Affairs within the pharmaceutical, vaccine, or biologics industry

Working knowledge of :

• Medicines and Related Substances Act (Act 101 of 1965), and the General Regulations thereof SAHPRA regulatory requirements and guidelines
• WHO PQ requirements for vaccines, biologicals and sterile products o GMP (SA, WHO, PIC/S) principles
• Experience with regulatory submissions, lifecycle management, and regulatory correspondence
• Exposure to audits, inspections, and regulatory compliance activities
• Demonstrated experience with CTD/eCTD dossier preparation
• Knowledge of Extedo or Docubridge
• Proven technical documentation compilation and regulatory writing skills, with the ability to critically evaluate and interpret data.

Preferred:

• Working knowledge of Pharmaceutical Manufacturing related legislation
• Knowledge of Marketing Code of practice
• Experience in registering product in African Continent
• Experience in having faced successfully local and/ or international quality audits.

Core Technical Delivery Regulatory Dossier Compilation & Submissions

• Author, compile, review, and maintain regulatory documentation and dossiers, for product registrations, variations, renewals, and post-approval changes in accordance with SAHPRA, WHO PQ, and other applicable NRA requirements
• Provide scientific input into regulatory dossiers, including quality, non-clinical, and clinical overviews where applicable, ensuring consistency with approved manufacturing and control strategies
• Support initial registrations, variations, renewals, and post-approval changes for pre and post registration products
• Ensure dossiers comply with SAHPRA, WHO PQ, AMRH/AMA, and country-specific NRA requirements
• Compile and update RA documents e.g. PI/PIL, labels, artwork, adverts and responses to RA authorities
• Ensure consistency, accuracy, and scientific integrity of regulatory documentation across submissions
• Participate in lifecycle management activities for registered products, including change control impact assessments, variation classification and tracking; and label updates and product information maintenance
• Ensure alignment between registered dossiers and current manufacturing, quality, and control documentation
• Preparation of Module 1 (regional) and Modules 2–5 content in alignment with SAHPRA, WHO PQ, and other NRA requirements
• Participate in and lead regulatory gap analyses and implementation of new regulatory requirements
• Prepare responses to regulatory authority questions and deficiency letters
• Responsible for regulatory document management and administrative duties
• Participate in regulatory activities in the assigned portfolio

Regulatory Compliance & Intelligence

• Monitor, interpret, and communicate changes in regulatory requirements, guidelines, and standards relevant to vaccines and biologics
• Support impact assessments for regulatory changes and contribute to implementation plans
• Ensure alignment of regulatory activities with Medicines Act (Act 101 of 1965), SAHPRA GMP Guidelines, WHO Technical Reports, and relevant ICH guidelines (as applicable to vaccines)
• Evaluate and recommend regulatory actions related to deviations, investigations, change controls, and CAPAs in accordance with internal SOPs, escalating significant regulatory risks to management as required
• Participate in departmental risk assessments, track mitigation actions, and report regulatory risks and trends to management
• Ensure regulatory documentation complies with internal QMS procedures and data integrity principles
• Maintain accurate records of submissions, approvals, commitments, and regulatory correspondence in approved systems
• Contribute to continuous improvement initiatives within the department
• Participate in internal audits, self-inspections, and external regulatory inspections
• Collaborate closely with Quality Assurance during audits and inspections to ensure alignment between regulatory commitments and operational practices.

Third-Party & External Engagement

• Support audits of third-party manufacturers, laboratories, and service providers from a regulatory perspective, including review of audit reports and follow-up of regulatory commitments
• Provide regulatory input into technical agreements, quality agreements, and supply contracts, escalating complex issues to management as required.

Systems, Documentation & Governance

• Ensure regulatory SOPs, work instructions, and templates are compiled, reviewed, updated, and maintained in compliance with internal document control requirements
• Contribute to the preparation, training matrices, and competency requirements within the Regulatory Affairs function, as delegated
• Maintain accurate and inspection-ready regulatory records in approved document management systems
• Maintenance of electronic folders (NRA guidelines and other related documentation)
• Responsible for tracking of regulatory activities
• Responsible for filing of any correspondence/ submissions / electronic submission support

Cross-Functional Collaboration

• Work collaboratively with internal and external stakeholders to ensure regulatory alignment across operations
• Participate in quality management and cross-functional governance meetings, representing Regulatory Affairs and communicating key outcomes and action items to management when required.

Technical Competencies required to perform this aspect of the role :

• Excellent understanding and working knowledge of regulatory and systems
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Regulatory
• Documentation Management
• Environmental, Health & Safety Management
• Data Analysis
• Metric Development & Regulatory Writing
• Coaching & Mentoring of peers & staff
• High attention to detail and data integrity
• Ability to interpret complex regulatory requirements and apply them practically
• Effective stakeholder communication and cross-functional collaboration
• Strong organizational and d