Associate Director, Regulatory Affairs, Oncology

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

Job Description

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 define the regulatory strategy, plans and objectives for assigned products or projects.

Responsibilities

• 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.
• 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.
• Oversees and approves the authoring of regulatory documents.
• Oversees and guides labeling, packaging and associated information updates and maintenance.
• Critically reviews documents for submission to regulatory authorities.
• Provides matrix management and leadership to project teams.
• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Requirements

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.

Rest Of World Education & Experience

BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment.

Knowledge & Other Requirements

• In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products.
• In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs.
• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities.
• In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements.
• Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
• Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.
• When needed, ability to travel.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit select and employ the most qualified persons available for positions throughout the Company.