Senior Regulatory Affairs Pharmacist / Associate

2705 Roche Products Limited; Johannesburg; On-site; ZAR 500,000 - 800,000; Full time

Job summary

Roche Pharma seeks a Senior Regulatory Affairs Pharmacist / Associate in Johannesburg. You will secure medicine registrations and ensure compliance with legislation while advising on regulatory processes. Ideal candidates possess a pharmacy qualification and 5-7 years' experience in the pharmaceutical field.

Qualifications

• 5–7 years' experience in the pharmaceutical or regulatory environment.
• Knowledge in ACT 101 and related regulations.

Responsibilities

• Secure registration of medicines and maintain current product dossiers.
• Monitor compliance with local legislation and ensure timely submissions.
• Provide guidance on local medicine legislation to Roche departments.

Skills

Communication

Planning

Organizing

Analytical Thinking

Attention to Detail

Education

NQF 8 in Pharmacy or a Science-related field

Registered Pharmacist

Job description

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

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity

Roche Pharma is seeking a Senior Regulatory Affairs Pharmacist / Associate to join their team in Johannesburg. Your primary responsibility is to secure the registration of medicines, obtain approval for new product indications in alignment with the business strategy, and maintain current product dossiers.

Key Challenges

Strategic Planning

• Advising on the most suitable time for submitting dossiers / new indications according to Roche Global timeframes and ensuring registration / approval by the health authority in the shortest possible time.
• Coordinate, monitor, and supervise timely submission and maintenance of dossiers in accordance with corporate and local directives, guidelines, SOPs, and legislative requirements.
• Gather, analyze, and communicate internal and external regulatory intelligence.
• Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g., market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.).
• Develop innovative, risk-based registration plans and submission strategies for Affiliate products with limited guidance from DRA Management.

Operational

• Monitor Roche Pharma's compliance with all local legislation relating to medicines and pharmacy practice, identify anomalies, and implement corrective actions.
• Review and prioritize the product registration portfolio, aligning it with business needs and market trends.
• Compile dossiers and submit in accordance with requirements, ensuring timely execution.
• Manage complex products, support special projects, and assist in onboarding and training DRA colleagues.
• Assist Product Teams with advertising material approval and legal compliance.

Stakeholder Management

• Provide advice and guidance to Roche departments regarding local medicine, pharmacy legislation, and internal guidelines.
• Support local market access activities from a regulatory perspective.

Filings

• Adapt global product dossiers to local requirements.
• Manage regulatory registration filings across product lifecycles.
• Monitor and communicate filing statuses, respond to questions, and address other needs.

Information and Document Management

• Manage regulatory activities on Roche systems.
• Review and update SOPs and related documents.

Regulatory Compliance

• Maintain knowledge of international and local regulations and practices.
• Prepare for inspections and ensure regulatory compliance of marketed products.
• Manage local product packaging and labelling from a regulatory perspective.

Who You Are as an Ideal Candidate

Qualifications & Experience

• NQF 8 in Pharmacy or a Science-related field
• Registered Pharmacist
• 5–7 years' experience in the pharmaceutical or regulatory environment

You must have knowledge in:

• ACT 101 (Medicines Control and Related Substances Act)
• All related medicines regulations and guidelines

Recommended skills & abilities

• Communication, planning, organizing, prioritizing
• Analytical thinking, accuracy, attention to detail
• Relationship management, decision-making

Physical requirements

• Ability to travel nationally and internationally

Who We Are

A healthier future drives us to innovate. Over 100,000 employees worldwide are dedicated to advancing science and ensuring access to healthcare. Our efforts have resulted in millions treated with our medicines and billions of tests conducted. We empower each other to explore new possibilities and deliver life-changing healthcare solutions. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.