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The Position

Roche Pharma is seeking a Senior Regulatory Affairs Pharmacist/Associate to join their team in Johannesburg.
Your main purpose is to effect registration of medicines and obtain approval for new indications of products according to the business strategy, as well as maintain current product dossiers

Key Challenges
 

Strategic /Tactical/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 timeous submission and maintenance of dossiers in accordance with corporate and local directives, guidelines, SOP’s and legislative requirements.

• Gather, analyse 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. 

• Represent Affiliate Regulatory in cross-functional teams.

• Handling more complex or larger-scale products to support, take a lead on special projects, and help on-board and train less experienced DRA colleagues in the assigned affiliate

Operational

• To monitor that Roche Pharma complies with all aspects of local legislation relating to medicines and pharmacy practice as well as other internal guidelines, directives and SOP’s, identify anomalies and implement corrective action.

• Review and prioritise the product registration portfolio and align it with the business needs and objectives, in line with market trends and developments.

• Compile dossiers and submit in accordance with corporate, legislative and health authority requirements and are executed timeously.

• Manage complex or larger scale products to support, take a lead on special projects, and help on-board and train DRA colleagues.

• Assist the Product Teams with the approval of advertising materials and reviewing and aligning with the legal advertising requirements.

• Collaborate with Quality Assurance in the final approval of packaging materials for the commercial pack

Customer Focus and Stakeholder Management

• Provide advice and guidance to relevant Roche departments regarding local medicine, pharmacy legislation and pharmacy practice, internal guidelines, directives and SOP’s.

• Support local market access activities from a regulatory perspective

• Influence internal and external stakeholders for successful regulatory outcomes
   

Filings

• Adapt global product dossiers to local requirements.

• Prepare and manage regulatory registration filings across product lifecycles.  

• Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs. 

• Prepare and submit regulatory filings and approvals
   

Information and Document Management

• Manage regulatory activities on relevant Roche systems

• Review SOPs and compile new and update existing documents in line with requirements

Regulatory Compliance

• Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards. 

• Prepare for regulatory inspection-readiness

• Monitor regulatory compliance for product released to market according to marketing authorisations, identify anomalies and implement corrective action

• Manage end-to-end local product packaging and labelling from a regulatory perspective.

• Review and approve promotional materials to provide regulatory input and guidance across the Affiliate.

• Provide regulatory administrative support for local lot releases

Who You Are as an Ideal Candidate

Qualifications & Experience

• NQF 8 in Pharmacy or in a Science related field

• Must be a registered Pharmacist

• 5 – 7 years experience in the pharmaceutical environment and/or regulatory environment

You must have knowledge in:

• ACT 101 (Medicines control and related

• substances Act)

• All related medicines regulations

• All related guidelines relevant to ACT 101

• Quality and Compliance

In the absence of relevant qualifications, experience in the relevant field and at the relevant level will be considered

Recommended skills & abilities

• Communication

• Planning, organising and prioritising

• Analytical thinking

• Accuracy and attention to detail

• Relationship management

• Innovation

• Adaptability

• Decision making

Physical requirements

• Ability to travel nationally and internationally

Note that a full job description is available at request.

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.