Manager, Regulatory Operations

Gilead Sciences•Foster City, CA

8h•Onsite

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Regulatory Publishing is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner with other Global Regulatory Affairs groups, collaborating closely with cross-functional teams by providing a range of publishing and document processing services, including regulatory publishing vendor management, and publishing / documentation processing innovations, such as new technologies, tools, and streamlined business processes. Responsibilities of this role include acting as a lead for Publishing of Regulatory documentation and Regulatory submissions. The responsibilities include Document Processing/report-level publishing, as well as compilation and publishing of complete submissions, ensuring timely and compliant regulatory submissions to global health authorities, and continuously optimizing processes and deliverables through digital and innovative solutions. Responsibilities include supporting authors, generating and managing templates, formatting documents, and publishing reports in adherence to global agency and Gilead standards. May also act as lead on projects or recurring activities that enhance the operations and work of Regulatory Publishing, to include technology or related projects, process, procedures, policy or standards updates, and training, education and awareness efforts to ensure other groups and teams to understand the role, responsibilities, services, standards, processes, and procedures for the work of Regulatory Publishing. Routinely supports hiring, on-boarding, training, mentoring, and coaching of new or less experienced colleagues.

Requirements

6+ Years with BS/BA OR 4+ Years with MS/MA
BA/ BS with 6+ years of relevant publishing/regulatory operations experience in the biopharma industry, or; MA/MS with 4+ years’ relevant experience
Regulatory operations experience ideally in a life sciences industry environment, including experience working with regulatory submissions publishing and regulatory document processing.
Advanced knowledge of Regulatory Publishing and Regulatory Affairs in an industry environment, with the ability to perform routine work independently.
Sufficient cross-functional knowledge of the biopharma industry and Gilead's overall business to participate in ad hoc activities, such as technology enhancements, and training other colleagues on the work, role, and support services of Regulatory Publishing.
Effectively leads and contributes to compliance maintenance.
Determine how to structure and manage increasingly complex deliverables to ensure these are completed on-time, within budget and to the quality expected.
Communicates in a way that enables alignment with others and gets people moving in the right direction.
Actively seeks and incorporates input from others to improve business and team outcomes.
Knows how to identify and plan for change management and effectively applies and incorporates this into assigned work.
Consistently identifies and aligns the right stakeholders to the right work.
Consistently meets stakeholder expectations, as evidenced through stakeholder feedback.
Understands strategic planning.
Identify opportunities to innovate and/or streamline.

Responsibilities

Manages task assignments and output quality of others supporting their work, which may include internal colleagues as well as publishing vendor staff.
Responsible for identifying synergies across assigned work to leverage efficiencies and ensure consistencies where appropriate.
Provide non-routine support for complex tasks.
Routinely represents Regulatory Publishing to Regulatory leaders and teams for assigned workstreams and projects.
Lead and participate in projects and recurring activities that enhance Regulatory Publishing operations, such as technology updates, process improvements, and training.
Oversee and manage regulatory publishing vendors and their work product.
Provide direction and oversight to other team members.
Lead Regulatory Publishing projects and workstreams.
May lead work related to authority contacts and negotiations, and lead industry and agency user acceptance tests (UATs).
Lead onboarding and training of new or less experienced colleagues.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.