Associate Director, Regulatory Affairs

Job Description

Key Responsibilities

• Lead and develop the Regulatory Affairs team providing clear direction and people management.
• Develop and execute regulatory strategies to secure timely approvals and maintain optimal product positioning.
• Ensure timely submission approval and lifecycle management of marketing authorisations including new applications variations renewals and major indications.
• Provide strategic regulatory guidance to support product development launches business development and market access initiatives.
• Maintain compliance with local regulatory requirements company policies and quality standards.
• Monitor and communicate regulatory intelligence legislative changes and emerging regulatory trends.
• Build and maintain effective relationships with health authorities industry associations and key external stakeholders.
• Represent Regulatory Affairs in inspections audits and cross-functional business initiatives.
• Support clinical trials safety reporting labelling promotional review and other regulatory compliance activities.
• Drive regulatory policy engagement and advocacy activities to shape the external regulatory environment.
• Collaborate closely with regional global and local stakeholders to achieve business objectives and accelerate patient access to medicines.
• Ensure effective implementation of regulatory systems databases procedures and training programme.
• Manages coaches and develops talent. Maintain scientific knowledge and expertise for our companys therapeutic areas.
• Establishes a regular system of communication of the department to update information on the status of main activities and mainly to share experiences discuss strategies and put in common lessons to be learned.
• Administers the departmental budget.

Qualifications & Experience

• Bachelors degree in Pharmacy (required).
• Minimum 6 years experience in Regulatory Affairs or a related pharmaceutical regulatory function including direct engagement with regulatory authorities.
• Demonstrated and significant experience working with the South African Health Products Regulatory Authority (SAHPRA) is essential.
• Experience across Sub-Saharan Africa will be advantageous.
• Sound knowledge of South African pharmaceutical legislation regulations and regulatory guidelines.
• Minimum 3 years experience in people leadership and team management.

Skills & Competencies

• Strong verbal and written communication skills.
• Excellent planning organisational and project management capabilities.
• High attention to detail and commitment to quality and compliance.
• Ability to manage multiple priorities and perform effectively under pressure.
• Strong stakeholder management negotiation and influencing skills.
• Demonstrated ability to lead coach and coordinate teams in a cross-functional environment.
• Strategic thinker with the ability to translate regulatory requirements into business solutions.

Required Skills:

Preferred Skills:

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