Senior Regulatory Affairs Pharmacist

AtripleA recruitment & temps; Johannesburg; Presencial; ZAR 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

The Senior Regulatory Affairs Pharmacist in Johannesburg will lead regulatory activities to ensure registration, maintenance and lifecycle management of the company''s product portfolio. You will provide technical guidance to the Regulatory Affairs team and coordinate with SAHPRA and other stakeholders.

Responsibilities include dossier submissions (CTD/eCTD), lifecycle management, and regulatory due diligence for new opportunities, while mentoring the team and driving process improvements.

Formación

• B. Pharm degree and SAPC registration.
• Minimum 5 years' Regulatory Affairs experience in pharma.
• Experience mentoring or leading Regulatory Affairs project teams.
• Solid knowledge of SAHPRA requirements and CTD/eCTD submissions.
• Experience with regulatory document management systems.

Responsabilidades

• Regulatory compliance: ensure SAHPRA adherence and guidelines across the portfolio.
• Dossier & lifecycle management: compile, review and submit CTD/eCTD dossiers; manage product changes.
• Business support: review promotional materials and artwork for compliance; support launches.
• Leadership & team development: guide and mentor Regulatory Affairs team; plan workload.
• Operational excellence: monitor submission timelines; identify process improvements and digital tooling.

Conocimientos

Regulatory affairs

Leadership

Planning

Stakeholder management

Analytical thinking

Educación

B. Pharm degree

Herramientas

DocuBridge

eCTD

Descripción del empleo

Job Title: Senior Regulatory Affairs Pharmacist

Location: Johannesburg

The Senior Regulatory Affairs Pharmacist is responsible for managing and coordinating regulatory activities to ensure the successful registration, maintenance and lifecycle management of company's product portfolio. The role provides technical guidance to the Regulatory Affairs team, supports business objectives through sound regulatory decision-making, maintains effective relationships with SAHPRA and other stakeholders, and contributes to the continuous improvement of regulatory systems and processes.

Key Responsibilities

Regulatory Compliance

• Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act and applicable regulatory guidelines.
• Maintain awareness of regulatory changes and communicate their business impact.
• Build and maintain effective working relationships with SAHPRA and other regulatory authorities.
• Provide regulatory guidance to internal stakeholders to ensure ongoing compliance.

Dossier & Lifecycle Management

• Independently compile, review and submit CTD/eCTD dossiers for new registrations, variations, renewals, transfers of ownership and other regulatory applications.
• Compile and review supporting scientific and administrative documentation to ensure high-quality submissions.
• Coordinate and prepare responses to SAHPRA queries and deficiency letters within agreed timelines.
• Manage the lifecycle of assigned products, including PI/PIL updates, labelling changes and implementation of approved variations.
• Maintain accurate regulatory records, document management systems and submission trackers.

Business Support

• Provide regulatory support for new product launches and lifecycle activities.
• Review and approve promotional and marketing materials to ensure compliance with regulatory requirements and approved product information.
• Review artwork, labels, PI/PILs and packaging components for regulatory compliance.
• Partner with Marketing, Supply Chain, Manufacturing and New Business Development on regulatory matters.
• Support regulatory due diligence for new business opportunities where required.

Leadership & Team Development

• Provide day-to-day guidance, mentoring and technical support to Regulatory Affairs team members.
• Support workload planning, prioritisation and achievement of departmental objectives.
• Promote collaboration, knowledge sharing and continuous improvement within the team.

Operational Excellence

• Monitor submission timelines and portfolio priorities.
• Identify opportunities to improve regulatory processes, systems and digital tools.
• Support implementation of automation and process improvements.

Minimum Requirements

• B. Pharm degree and current SAPC registration.
• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry.
• Demonstrated experience mentoring, coaching or leading Regulatory Affairs team members or projects.
• Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management.
• Proven ability to independently compile and submit regulatory dossiers and manage regulatory authority interactions.
• Experience with DocuBridge/eCTD or equivalent regulatory document management systems.

Behavioural Competencies

• Strong technical regulatory knowledge
• Leadership potential and ability to mentor others
• Excellent planning and organisational skills
• Strong communication and stakeholder management
• Analytical thinking and sound judgement
• Accountability and attention to detail
• Collaborative approach and continuous improvement mindset

Decision-Making Authority

• Recommend regulatory approaches for submissions and lifecycle activities.
• Prioritise workload within agreed departmental objectives.
• Escalate regulatory risks and compliance issues where appropriate.
• Represent the department during routine interactions with SAHPRA and external partners.
• Utilise existing proven relationships with SAHPRA to support regulatory submissions, communications, and compliance activities.