Hybrid Senior Manager, Regulatory Affairs – Virology

at Gilead Sciences

• Job title: Senior Manager, Regulatory Affairs – Virology
• Job type: Full Time
• Experience level: Senior
• Salary: $143,225 - $203,940 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Foster City, United States

About the role

• Regional Regulatory Lead in Virology at Gilead. Define regulatory strategy and lead submissions for assigned projects.

Responsibilities

• You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in Virology.
• With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects.
• You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams.
• You may serve as a Gilead contact to / for regulatory authorities.
• You will oversee and manage the work of less experienced colleagues supporting your work.
• You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities.
• You will typically be assigned products, compounds, indications or projects of increasing complexity.
• You will also typically play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams.

Requirements

• Doctorate and 2+ years of relevant experience OR Master’s and 6+ years of relevant experience OR Bachelor’s and 8+ years of relevant experience
• Significant regulatory, quality, compliance or related experience supporting medicinal products.
• Significant regulatory experience in the biopharma industry is strongly preferred.
• Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred.
• Experience successfully leading departmental and cross-functional teams without authority.
• Experience authoring and implementing processes.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives, including ICH standards and the regulatory requirements for assigned markets.
• In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
• Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations.
• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
• Ability to lead and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.
• When needed, ability to travel.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans*
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off
• benefits package