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 company's 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

• Bachelor’s 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:

Adaptability, Cross-Functional Teamwork, Data Management, People Management, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Operations, Regulatory Policies, Regulatory Submissions, Strategic Thinking, Teamwork

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/5/2026

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