Overview
Associate Director, Regulatory Affairs, Oncology — Gilead Sciences
Join to apply for the Associate Director, Regulatory Affairs, Oncology role at Gilead Sciences. For more than 35 years, Gilead has tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer, developing therapies to improve lives and expand access globally. Our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. We strive to create an inclusive environment where leadership, development and empowerment enable every employee to fulfil their aspirations.
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 typically lead multiple products or projects, define regulatory strategy, plans and objectives, and 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 regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding colleagues to ensure thorough and compliant completion. You will play a leadership role in ad hoc or special projects to advance Regulatory Affairs capabilities.
Responsibilities
- As needed, represents Gilead in negotiations with regulatory authorities.
- Contributes to the 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.
- Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assigns such tasks to others and guides their participation.
- Defines the regulatory strategy for multiple Gilead products or projects.
- Identifies regulatory or related risks/issues and develops mitigation/contingency plans.
- Oversees the preparation, compilation, and timely filing of regulatory submissions requiring cross-functional interactions (e.g., meeting requests, briefing packages, INDs, IND amendments, DSURs, IB updates).
- Oversees and approves the authoring of regulatory documents, including meeting requests and Module 1 documents for original INDs.
- Oversees and guides labeling, packaging and related information updates in accordance with product licenses for assigned products and markets.
- Critically reviews documents for submission to regulatory authorities.
- Provides matrix management and leadership to project teams.
- Provides input into resource plans and tracks resources to ensure compliance with budgets and allocations.
- Ensures work complies with established practices, policies, processes and regulatory requirements.
Requirements
We are all different, yet we all use our unique contributions to serve patients. Please review the qualifications and skills for this role.
Education & Experience: BA/BS or advanced degree in life sciences or related field with significant regulatory experience in biopharma, regulatory agency, clinical research or related healthcare environment. Experience leading a broad range of regulatory activities and setting regulatory strategy for biopharmaceutical products.
Knowledge & Other Requirements
- In-depth understanding of FDA and EMA regulatory requirements and ICH standards for medicinal products; understands varying regional regulatory requirements for assigned markets.
- Awareness of global and regional trends in regulatory affairs with ability to apply insights to team deliverables.
- Strong regulatory and business knowledge with analytical abilities to assess complex data and advise on regulatory implications.
- Thorough knowledge of health authorities, processes and requirements; evidenced by past interactions and successes.
- Ability to represent Gilead to regulatory authorities in standard and non-standard negotiations.
- Strong understanding of the drug development process from early research through post-marketing.
- Proven leadership presence with ability to influence programs and initiatives.
- Strong interpersonal, communication and organizational skills; effective negotiation and conflict resolution abilities.
- Willingness and ability to travel when needed.
Equal Employment Opportunity (EEO): It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit and employ the most qualified persons for positions, and to administer employment actions on a non-discriminatory basis in accordance with applicable laws. Gilead also prohibits discrimination based on protected characteristics.
For Current Gilead Employees And Contractors: Please apply via the Internal Career Opportunities portal in Workday.
