Senior Regulatory Affairs Pharmacist

Roche; Johannesburg; On-site; ZAR 300 000 - 700 000; Full time

Job summary

Join a forward-thinking company as a Senior Regulatory Affairs Pharmacist, where your expertise will play a vital role in ensuring the registration of medicines and compliance with local legislation. This position offers a unique opportunity to influence healthcare access and contribute to innovative solutions that improve lives. Collaborate with diverse teams and external stakeholders while developing your career in a supportive environment. If you are passionate about advancing healthcare and thrive in a dynamic setting, this role is perfect for you.

Qualifications

• 5-7 years Pharma experience with exposure to Regulatory Affairs.
• Ability to interpret medicines legislation and guidelines.

Responsibilities

• Ensure registration of medicines and approval for new indications.
• Maintain product dossiers and comply with local legislation.
• Advise on advertising and packaging materials.

Skills

Pharmacy Degree (BPharm)

Regulatory Affairs knowledge

Excellent communication skills

Interpersonal skills

Networking skills

Analytical skills

Computer literacy (PowerPoint, Excel)

Education

Pharmacy Degree (BPharm)

Tools

Microsoft PowerPoint

Microsoft Excel

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

Make your mark. Improve lives.
Join our team in Roche Pharma as a Senior Regulatory Affairs Pharmacist!

As a Senior Regulatory Affairs Pharmacist, you will ensure the registration of medicines and obtain approval for new indications of products according to the business strategy, as well as the maintenance of current product dossiers.

Your Key Activities will Include:

1. Providing advice on submitting dossiers/new indications and ensuring registration by the health authorities in the shortest possible time.
2. Ensuring maintenance of dossiers in accordance with company directives, SOP’s and legislative requirements and that Roche pharma complies with all aspects of local legislation and internal guidelines relating to medicines and pharmacy practices.
3. Ensuring product registration portfolio reflects the business needs and objectives, in line with market trends and developments.
4. Assisting with the approval of advertising and packaging materials, ensuring that these are in line with the legal requirements.
5. Providing advice and guidance to relevant departments regarding local medicine pharmacy legislation and pharmacy practice, internal guidelines, directives and SOP’s.
6. Establishing and maintaining relationships with key external market stakeholders (eg IPASA, MRA/SAHPRA).

Who You Are as an Ideal Candidate

You are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

This challenging role requires the following experience and skills:

1. Pharmacy Degree (BPharm).
2. Previous Pharma experience 5-7 years and exposure to Regulatory Affairs would be advantageous.
3. Demonstrate knowledge of and ability to interpret all related medicines legislation and guidelines.
4. Ability to prioritise and analyse detailed information.
5. Excellent communication written and oral skills.
6. Good interpersonal skills and stakeholder collaboration across all levels.
7. Excellent networking skills.
8. Ability to work independently and within teams.
9. Ability to abide by values and procedures that reflect organisational and professional norms.
10. Demonstrated computer literacy in PowerPoint at intermediate level and excel at basic level.
11. Supervisory experience will be an added advantage.

Note that a full job description is available upon request.

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.