BridgeBio · 2 days ago

Sr. Director, Global Regulatory Affairs Labeling

Remote - United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$245K/yr - $285K/yr

10+ years exp

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BiotechnologyHealth Care

Growth Opportunities

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Responsibilities

Provide regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation

Collaborate closely with BridgeBio regulatory teams and subject matter experts to implement regulatory strategies and oversight of global labeling activities

Partner with Regulatory Affairs, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and lead the Label Working Group

Input to requirements for tools and systems for the compliant management of labeling documents to ensure that work is performed in accordance with established procedures and GxPs

Maintain awareness of global regulatory environments and assess the impact of changes on product labeling activities throughout development and commercialization

Provide strategic interpretations of labeling regulations and guidelines in a range of markets, including the US and EU. This can be accomplished by managing and utilizing local resources (e.g., in-country or in-region labeling consulting services)

Develop, improve, implement, and document best-in-class labeling processes, metrics, and templates, including influencing stakeholders at all levels to ensure that good labeling process is followed throughout the product lifecycle

Directly oversee and provide strategic and tactical advice for the maintenance and development of CCDS and local labeling deliverables for regulatory filings

Monitor consistency between local labeling documents and CCDS, and ensure exceptions are documented through standard process

Review and approve all change requests for revised labeling for assigned products

Prepare labeling strategic plans and participate in label related Health Authority negotiations

Review final artwork to be implemented into production

Qualification

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PharmacyBiologyChemistryMicrobiologyPharmaceutical ExperienceUS Product LabelingEU Product LabelingCCDS DevelopmentLeadership ExperienceRegulatory Affairs CertificationScientific PrinciplesRegulatory/Quality SystemsInterpretation of RegulationsUSPI CreationEU SmPC CreationProject ManagementRelationship Building