• , US

Company:  Confidential

Job Title: Global Regulatory Strategy Lead

Job Number: 79104

Location: , US

Job 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.

Application Deadline: 2024-07-08

 

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