Director Regulatory Affairs South Africa

Haleon; Johannesburg; On-site; ZAR 400,000 - 500,000; Full time

Job summary

A leading consumer health company in Johannesburg seeks an experienced regulatory operations leader. The role involves monitoring regulatory changes, advising on compliance procedures, and managing regulatory relationships. Candidates must have at least 15 years of regulatory experience and a degree in pharmacy or related fields. This is an opportunity to be part of a company dedicated to improving everyday health.

Qualifications

• Minimum of 15 years regulatory experience required.
• Robust knowledge of industry and business model needed.
• Ability to address complicated regulatory challenges.

Responsibilities

• Lead all regulatory and market access operations.
• Monitor and report on regulatory changes impacting operations.
• Advise on procedures for local regulatory compliance.

Skills

Regulatory experience

Knowledge of healthcare regulations

Strategic planning

Education

University degree in Pharmacy or related health sciences

Job description

Overview

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About the role

Role focus: Leading all regulatory and market access operations

Responsibilities

• Monitor and report on Regulatory changes that impact South Africa business operations/opportunities for OTC pharmaceuticals, cosmetics, food supplements and medical devices; assess and promote compliance with existing and new laws and regulations
• Advise/develop procedures for time and cost efficient local regulatory compliance
• Develop regulatory strategies and implementation plans for the preparation, submission and acceleration of new products/innovations
• Build relationships with relevant government agencies, notified bodies, local associations
• Respond to inquiries from regulatory authorities
• Provide awareness and training to functional groups in the markets, as appropriate
• Independently prepares documentation and procedures related to responsibilities; continuously looks for process & resource effectiveness and improvement opportunities
• Establish regulatory priorities or budgets and allocate resources and workloads
• Manage activities such as audits, regulatory agency inspections, or product recalls
• Work closely with Haleon local manufacturing site and lead regulatory advice and processes
• Implement team goals or objectives, supervise, train, motivate or guide team members clearly if needed, and be knowledgeable about each team member’s job role

Qualifications and skills

Essential

• A university degree: Faculty of pharmacy or related health sciences
• 15 years and more regulatory experience
• Robust knowledge of industry, business model & core strategic processes and understanding the value-added role of regulatory in strategic brand/portfolio planning
• Robust knowledge of healthcare and regulatory environment, external environment and competitor pipelines/portfolios and ability to use knowledge to weigh up challenges and risks; more accountability for decision making and for solving complicated situations
• We have a strong preference to include and grow our population of South African Professionals

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Diversity, Equity and Inclusion

We embrace a diverse workforce by creating an inclusive environment that celebrates unique perspectives, fosters curiosity, and promotes fair and equitable outcomes for everyone. We strive to celebrate diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all roles; if flexibility is important to you, explore with our hiring team what opportunities are available.

Care to join us? Find out what life at Haleon is really like at www.haleon.com/careers/

As you apply, we may ask you to share some personal information. This is voluntary and helps us consider a diverse pool of qualified candidates. Hiring Managers do not have access to this information and we treat all information confidentially. Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or any other protected class.

Accommodation

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process.