Associate Director, Regulatory Affairs

MSD South Africa; Johannesburg; Hybrid; ZAR 1,800,000 - 3,200,000; Full time

Job summary

Merck & Co., Inc. in Johannesburg seeks a Regulatory Affairs leader to direct the team, shape regulatory strategies, and ensure timely approvals and lifecycle management for marketing authorisations across SA and regional markets.

You will provide strategic guidance for product development, launches, and market access while ensuring compliance with SAHPRA and global regulatory standards. Hybrid work arrangements are available.

Qualifications

• Strong communication skills, both oral and written.
• Excellent planning, organisational and project management capabilities.
• High attention to detail and commitment to quality and compliance.
• Ability to manage multiple priorities and work under pressure.

Responsibilities

• Lead and develop the Regulatory Affairs team with clear direction and people management.
• Develop and execute regulatory strategies for timely approvals and product positioning.
• Oversee submissions, approvals, lifecycle management, variations and major indications.
• Provide strategic regulatory guidance to support development, launches and market access.
• Maintain compliance with local regulations, company policies and quality standards.
• Monitor regulatory intelligence and evolving regulatory trends; advise on policy engagement.
• Build relationships with health authorities and external stakeholders.
• Represent Regulatory Affairs in inspections, audits, and cross-functional initiatives.
• Support clinical trials, safety reporting, labeling, and promotional review.

Skills

Verbal & written communication

Planning & project management

Attention to detail

Stakeholder management

Leadership & coaching

Strategic thinking

Education

Bachelor’s degree in Pharmacy

Job description

Job Description

• 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.

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

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Search Firm Representatives Please Read Carefully

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.

Job Posting End Date

11/23/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R418315