Key Responsibilities:
Filings:
Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity.
Interact and negotiate with local HAs and internal stakeholders to build and cultivate trusted partnerships.
Influence internal and external stakeholders for successful regulatory outcomes.
Regulatory Compliance:
Maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.
Support regulatory inspection-readiness for the Affiliate, including participating in internal/external regulatory audits.
Ensure affiliate regulatory activities comply with Roche global standards and local regulations.
Strategy/Planning:
Contribute to Local regulatory strategies, considering local regulation and business needs.
As assigned, gather and disseminate regulatory intelligence within the Affiliate; involving regional and global organisations, when appropriate.
Participate in industry associations on regulatory policy and regulations.
Provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy etc.).
Develop innovative, risk-based regulatory strategies and workplans for assigned products or business areas within the Affiliate to accelerate access .
Other:
Manage relevant Affiliate regulatory activities on applicable Roche systems to ensure appropriate, thorough and timely regulatory information and document management.
Where applicable, manage end-to-end local product packaging and labelling from a regulatory perspective.
Where applicable, review and approve promotional materials to provide regulatory input and guidance to other Affiliate functions and teams.
As applicable, supervise and manage shipment clearance of Affiliate materials/products .
You, as an ideal candidate, will have the following skills, experience and education:
Essential: University Degree in Pharmacy and Practicing License is mandatory.
Experience: At least 2-5 experience in a Regulatory Affairs role.
Other requirements: Fluency in written and spoken English.
Job Level:
Individual contributor.
Apply via :
www.linkedin.com
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