Senior Regulatory Affairs Pharmacist/Associate — Roche

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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 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