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.
\n\n\n\n\n\nThe Position\n\nA 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.
\n\nCreating a world where we all have more time with the people we love.
\n\nThat’s what makes us Roche.
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The Opportunity
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Roche Pharma is seeking a Senior Regulatory Affairs Pharmacist/Associate to join their team in Johannesburg.\n\nYour 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.
\n\n\nKey Challenges
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Strategic Planning:
\n\n\n\tAdvising 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.
\n\t\n\t\n\tCoordinate, monitor and supervise timeous submission and maintenance of dossiers in accordance with corporate and local directives, guidelines, SOP’s and legislative requirements.
\n\t\n\t\n\tGather, analyse and communicate internal and external regulatory intelligence.
\n\t\n\t\n\tProvide 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.)
\n\t\n\t\n\tDevelop innovative, risk-based registration plans and submission strategies for Affiliate products with limited guidance from DRA Management.
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Operational:
\n\n\n\tTo 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.
\n\t\n\t\n\tReview and prioritize the product registration portfolio and align it with the business needs and objectives, in line with market trends and developments.
\n\t\n\t\n\tCompile dossiers and submit in accordance with corporate, legislative and health authority requirements and are executed timeously.
\n\t\n\t\n\tManage complex or larger scale products to support, take a lead on special projects, and help on-board and train DRA colleagues.
\n\t\n\t\n\tAssist the Product Teams with the approval of advertising materials and reviewing and aligning with the legal advertising requirements
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Stakeholder Management:
\n\n\n\tProvide advice and guidance to relevant Roche departments regarding local medicine, pharmacy legislation and pharmacy practice, internal guidelines, directives and SOP’s.
\n\t\n\t\n\tSupport local market access activities from a regulatory perspective
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Filings:
\n\n\n\tAdapt global product dossiers to local requirements.
\n\t\n\t\n\tPrepare and manage regulatory registration filings across product lifecycles.
\n\t\n\t\n\tMonitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
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Information and Document Management:
\n\n\n\tManage regulatory activities on relevant Roche systems
\n\t\n\t\n\tReview SOPs and compile new and update existing documents in line with requirements
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Regulatory Compliance:
\n\n\n\tDevelop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.
\n\t\n\t\n\tPrepare for regulatory inspection-readiness
\n\t\n\t\n\tMonitor regulatory compliance for product released to market according to marketing authorisations, identify anomalies and implement corrective action
\n\t\n\t\n\tManage end-to-end local product packaging and labelling from a regulatory perspective.
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Who You Are as an Ideal Candidate
\n\nQualifications & Experience
\n\n\n\tNQF 8 in Pharmacy or in a Science related field
\n\t\n\t\n\tMust be a registered Pharmacist
\n\t\n\t\n\t5 – 7 years experience in the pharmaceutical environment and/or regulatory environment
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You must have knowledge in:
\n\n\n\tACT 101 (Medicines control and related
\n\t\n\t\n\tsubstances Act)
\n\t\n\t\n\tAll related medicines regulations
\n\t\n\t\n\tAll related guidelines relevant to ACT 101
\n\t\n\t\n\tQuality and Compliance
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In the absence of relevant qualifications, experience in the relevant field and at the relevant level will be considered
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Recommended skills & abilities
\n\n\n\tCommunication
\n\t\n\t\n\tPlanning, organising and prioritising
\n\t\n\t\n\tAnalytical thinking
\n\t\n\t\n\tAccuracy and attention to detail
\n\t\n\t\n\tRelationship management
\n\t\n\t\n\tInnovation
\n\t\n\t\n\tAdaptability
\n\t\n\t\n\tDecision making
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Physical requirements
\n\n\n\tAbility to travel nationally and internationally
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\n\nWho we are\n\nA 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.
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\nLet’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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