• , US

Company:  Confidential

Job Title: Global Regulatory Strategy Lead – CMC

Job Number: 79105

Location: , US

Job Description

The Global Regulatory Strategy Leader (GRSL) CMC reports to the Head of Global Regulatory Affairs (GRA) and is responsible for developing and implementing global regulatory strategies for the Gates MRI portfolio. They are an expert in global CMC regulatory affairs, involved in product development and licensure worldwide, and work cross-functionally on product development teams. Responsibilities include strategic planning for CMC activities, organizational development, and participation in due diligence and partnering activities.

Responsibilities

* Develop global regulatory plan for CMC aspects. * Align with PDT on regulatory strategies. * Lead Health Authority interactions. * Provide input on clinical trial documentation and vendor selection. * Maintain documentation oversight. * Create regulatory documentation. * Represent regulatory perspectives. * Act as SPOC for CMC regulatory aspects. * Liaise with WHO and Health Authorities. * Prepare regulatory records for product transfer. * Stay updated on regulatory trends.

Required Skills

The ideal candidate will have: * 10+ years of regulatory strategy experience, with expertise in late-stage vaccine regulatory and small molecules/biologics. * Minimum MS degree, with a preference for a PhD or MD in a related field. * Proficient in all regulatory affairs activities including submissions, IND applications, and filings. * Skilled in regulatory pathway programs like breakthrough and accelerated approval. * Experience in developing and implementing CMC regulatory strategies globally. * Ability to resolve conflicting input from different regulatory authorities and manage timelines effectively. * Knowledgeable about ICH, FDA, and EMA regulations, as well as GLP, GMP, and GCP. * Proven effectiveness in a matrixed organization, anticipating and addressing regulatory risks collaboratively. * Strong communication skills and ability to work well under pressure. * Experience advising senior leadership and contributing significantly to product development. * Capability in building internal and external capabilities and navigating operational and strategic issues. * Passionate about values and committed to delivering results against the mission.

Application Deadline: 2024-07-08

 

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