Associate Director, Global Regulatory Affairs, Oncology

Senior Manager, Global Regulatory Affairs, Oncology

United Kingdom - Cambridge Regulatory Regular

Global Therapeutic Area (TA) Regulatory Liaisons

Overview

POSITION OVERVIEW :

You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.

Responsibilities

• As needed, represents Gilead in negotiations with regulatory authorities.
• Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
• Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional / cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
• May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
• Defines the regulatory strategy for multiple Gilead products or projects.
• Proactively identifies regulatory or related risks / issues and develops mitigation and / or contingency plan.
• Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure / IB updates, etc.).
• Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
• Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• May have one or more direct reports.
• Provides matrix management and leadership to project teams.
• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Qualifications

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

U.S. Education & Experience

Rest of World Education & Experience

Knowledge & Other Requirements

Job Details

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