The purpose of this role is to manage regulatory approval processes by understanding the requirements, monitoring and preparing submissions, engaging with key regulatory authorities and managing and driving approvals through the relevant processes as required.

You as the successful candidate will provide market relevant inputs into product design by understanding market requirements and regulatory frameworks, guiding design undertaken by Global, reviewing dossiers. development and providing feedback and recommendations to support regulatory approval across identified markets. You will manage implementation of Global regulatory strategies by identifying and developing regulatory approaches, encouraging engagement on proposed approaches and aligning for the respective market conditions as required and will manage maintenance of regulatory authorities by monitoring renewals, amendments and updates that are required and overseeing that all regulatory requirements are met as required. You will be responsible for managing the maintenance of licensing requirements by reviewing product file updates, variances and submissions, monitoring the status of the permits/licenses and addressing any delays or risks as required.

Key Challenges

Strategic /Tactical/Planning

• Advising on the most suitable time for submitting dossiers/new indications a cording 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 Documentation 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

You, as an ideal candidate, will have the following skills, experience and education:

• Required Qualification: University degree in one of the following or related scientific disciplines: Pharmacy, Medicine, Pharmaceutical Chemistry, Biology or Chemistry
• Required Experience: 3-5 years’ experience in pharmaceutical/medical device/quality assurance environment

Recommended Skills & Abilities

• Communication
• Planning, organising and prioritising
• Analytical thinking
• Accuracy and attention to detail
• Relationship management
• Innovation
• Adaptability
• Decision making

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.