Director of Regulatory Affairs - Pharmaceutical Company - Drug Manufacturer
The Head of U.S. Regulatory Affairs is responsible for leading strategic and operational management of US/North American regulatory affairs for the global clinical programs for early phase drug products. This role will provide leadership in developing strategic guidance and execution of regulatory concepts working with cross-functional project teams.
The Head of U.S. Regulatory Affairs will manage the company's relationship and engagement strategy with the Food and Drug Administration (FDA), provide leadership and expert advice to the Global Project Teams and global regulatory affairs, from the perspective of U.S. and global regulatory standards and expectations for regulatory strategy.
The role is also a key member of Global Regulatory Affairs management team overseeing the early Regulatory Affairs (RA) organization, including the delivery of optimal RA plans to meet the company's early development goals. This role will be expected to develop strong relationships with therapeutic area experts, the pipeline product teams, and other functions within company including the development partners such as Roche and Genentech.
The Head of U.S. Regulatory Affairs will also be responsible for informing senior leadership within the company on regulatory developments that may have an impact on the company's strategic activities.
Essential Duties and Responsibilities:
· Lead RA team to develop and implement competitive and effective regulatory strategies for products in early development in multiple therapeutic areas including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies.
· Provide effective leadership to ensure that regulatory project objectives and milestones set by
the RA Functional Teams/Global Project Teams are met, i.e. ensure that all US regulatory activities are executed in accordance with agreed timelines.
· Provide direct supervision, including oversight, support, mentorship, development and performance management of US Regulatory Leaders and other staff.
· When necessary, be able to serve as a Regulatory Leader on a project team.
· Manage and participate in the creation, review, assembly and submission of regulatory
documentation such as INDs, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials.
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