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Global Regulatory Strategy Lead
Description:
Reporting to the Head of Regulatory Strategy, the Global Regulatory Strategy Lead (GRSL) develops and implements global regulatory strategies for the Gates MRI portfolio. This role involves: * Developing innovative regulatory approaches with transparency and urgency. * Leading global regulatory affairs with experience in product development and licensure. * Collaborating cross-functionally on product development teams. * Documenting, implementing, and updating regulatory plans and Health Authority engagement plans for the portfolio's progression. Responsibilities * Implement global regulatory plans for product candidates. * Develop regulatory strategies for different candidate modalities. * Lead interactions with Health Authorities and communicate outcomes. * Provide input on clinical trial documentation and vendor selection. * Ensure compliance with quality activities. * Prepare regulatory documentation for clinical trials and licensure. * Collaborate with key stakeholders for regulatory advancement. * Stay updated on regulatory trends and support ongoing development. Required Skills * 8-10+ years of regulatory strategy experience with an advanced degree. * Experience in late-stage vaccine regulatory and small molecules/biologics. * Proficient in regulatory affairs, including submissions, IND applications, and filings. * Skilled in breakthrough and accelerated approval pathways. * Successful track record in global regulatory strategies and approvals. * Knowledgeable in ICH, FDA, and EMA regulations, as well as GLP, GMP, and GCP. * Effective management of external regulatory consultants and CROs. * Strong ability to address regulatory risks collaboratively and work under pressure.
Company:
Gates Medical Research Institute
Posted:
May 18 on jobRxiv
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Global Regulatory Strategy Lead is a Jobs Global Regulatory Strategy Job at Gates Medical Research Institute located in United States. Find other listings like Global Regulatory Strategy Lead by searching Oodle for Jobs Global Regulatory Strategy Jobs.
Global Regulatory Strategy Lead is a Jobs Global Regulatory Strategy Job at Gates Medical Research Institute located in United States. Find other listings like Global Regulatory Strategy Lead by searching Oodle for Jobs Global Regulatory Strategy Jobs.