Head of Regulatory

Posted 4 Days Ago
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Hiring Remotely in South Africa
Remote
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
As Head of Regulatory Affairs, lead strategic regulatory initiatives, manage compliance and stakeholder engagement, and oversee timely dossier submissions while fostering team growth.
Summary Generated by Built In

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As Head of Regulatory Affairs, you will play a pivotal role in ensuring Roche’s medicines are registered and compliant with current regulations, enabling the organization to operate optimally while maintaining its license to operate. You will lead the development of regulatory strategies, manage compliance, oversee stakeholder engagement, and contribute to Roche’s broader business objectives, always putting the patient first and following the science.

Key Challenges
  • Strategic leadership in regulatory affairs, balancing market trends with compliance requirements, and contributing to Roche’s long-term organizational ambitions.
  • Developing and implementing policies aligned with legislation, addressing non-compliance and evolving regulatory requirements.
  • Managing relationships with regulatory bodies, industry experts, and external stakeholders while providing guidance to cross-functional Roche teams.
  • Overseeing dossier submissions to ensure timely registration in compliance with national and international standards.
  • Team leadership, including building a talent pipeline, nurturing growth, and developing staff in line with a culture of learning and innovation.
Who You Are as Our Ideal Candidate

You have a strong entrepreneurial spirit, embracing both compliance and innovation to drive success. As an inclusive leader, you foster trust, inspire teams, and actively contribute to Roche’s reputation. You are proactive, self-managed, and able to act boldly, swiftly, and collaboratively, never losing sight of the patient-centric mission.

Your qualifications and experience include:

  • A relevant degree (NQF 7/8) in pharmaceuticals with extensive experience (7-10 years in regulatory affairs and 5-8 years in management).
  • Deep knowledge of pharmaceutical regulations, registration processes, and compliance frameworks.
  • A growth mindset, dedication to quality, and the ability to lead under pressure while managing complexity.
  • Exceptional skills in communication, strategic agility, influencing, teamwork, and innovation.

Are you ready to contribute to life-changing work that genuinely impacts patients, while fostering an environment where personal growth thrives? At Roche, you will experience diversity, inclusion, and a culture powered by collaboration with a global network. Your work will be meaningful, within a company that values agility, prioritization for impact, and a bold yet ethical approach to innovation.

Apply today and contribute to Roche's vision of bringing impactful solutions to patients worldwide!

Note that relocation benefits are not available for this role.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Top Skills

Compliance Frameworks
Pharmaceutical Regulations
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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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