Drug Regulatory Affairs Partner — 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 The Drug Regulatory Affairs Partner’s responsibilities are typically for regulatory activities across the product lifecycle, from early development through post-marketing activities. Develops and manages execution of regulatory strategies, regulatory projects, regulatory submissions and associated activities to ensure rapid and optimal registration for new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products. With teams, have interactions with local health authorities. With teams, develops and cultivates external relationships, such as with health authorities and other stakeholders or influencers. Ensures regulatory activities result in the timely approval and broadest use of products. Ensures regulatory activities are appropriately aligned with regional and global regulatory direction and guidance. Ensures timely, accurate and compliant regulatory documentation, standards, systems and procedures for regulatory activities. Helps ensure affiliate inspection-readiness at all times, as this relates to regulatory documentation and other regulatory activities. May participate in internal and external audits and post-auditing activities to address audit findings. Selects, develops and evaluates employees ensuring the efficient operation of the function. The role: Strategy/planning:

• Shape the regulatory environment by taking leadership roles in industry associations on regulatory policy and regulations.
• Contribute to and influence global regulation and business needs.
• Own regulatory intelligence gathering and dissemination across the Affiliate; involving regional and global organizations when appropriate.
• Lead regulatory affairs 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...)
• Lead and develop innovative, risk-based regulatory strategies and work plans for all products across the Affiliate to accelerate access in alignment with global. Fillings:
• Lead and provide strategic oversight of execution of all regulatory filling activities across product lifecycles, which may involve performing some of the work of DRA staff.
• Lead contact and negotiation with local Has and internal stakeholders to build and cultivate trusted partnerships.
• Ensure regulatory filings are aligned with commercial and supply needs to ensure business continuity significantly influence internal and external stakeholders for successful regulatory outcomes. Regulatory compliance:
• Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, systems and standards.
• Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits.
• Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations. Other:
• Oversee and guide end-to-end local product packaging and labelling from a regulatory perspective.
• Where applicable, oversee review and approvals of promotional materials to provide regulatory input and guidance across the Affiliate.
• As applicable, provide oversight of shipment clearance/QA release of Affiliate materials/products.
• Support local access market activities from a regulatory perspective.
• Overse