Manager, Regulatory Ops- Submission Management

At Gilead were creating a healthier world for all people. For more than 35 years weve 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. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

Manager Regulatory Submission Management

Regulatory Submission Management (RSM) acts as a partner for strategic planning and execution of the portfolio to ensure global Regulatory submissions are scalable seamless and optimized. We are a trusted companion across Regulatory Affairs (RA) bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster together.

This role is focused on submission planning and execution. You will execute a wide range of regulatory submissions independently including submissions of high complexity contribute to and manage global submission content plans and lead review and planning processes for multiple products or projects. You will represent RSM on relevant product project and/or regulatory submissions teams providing specialist guidance on regulatory submissions requirements and timing. You may also represent RSM on other cross-functional initiatives. You will plan and have oversight for assigned deliverables and may serve as an RSM lead for regulatory submissions. You will participate in identifying and developing process improvements new standards and updating systems in support of submissions. You may coach train and provide guidance to less experienced RSM colleagues.

Essential Duties and Job Functions:

• Manages the submission execution activities for a wide variety of global submission projects such as clinical study reports (CSRs) variations investigators brochures DSURs regulatory responses original INDs and amendments.

• May support regulatory portfolio planning activities or submission execution for multiple submissions of varying complexity including global marketing applications.

• Represents RSM in cross-functional teams such as product project and/or regulatory submissions teams; providing guidance for technical strategies to achieve fast frictionless filings or meet technical health authority requirements; may act as a technical and operational lead for submission execution.

• Plans and oversees assigned submissions with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions.

• Supports the planning and preparation of maintenance activities for early development and late-stage regulatory deliverables with direction from RA Liaisons.

• Organizes preparation of high-quality documents for submissions such as cover letters forms and other documents as assigned.

• Participates in development/improvement of submission standards submission templates and validation decision trees.

• May also participate in other special projects and/or represent RSM in other cross-functional initiatives.

• Where applicable oversees the work of external contractors supporting deliverables and other activities.

• Act as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables.

• May coach train and provide guidance to less experienced RSM colleagues.

• Ensures work complies with established practices policies and processes and any regulatory or other requirements.

Education & Experience:

• BA/ BS with relevant submission management or regulatory operations experience in the biopharma industry or relevant experience with MA/MS/MBA or relevant experience with PharmD/PhD.

• Significant experience in the biopharma industry is strongly preferred.

• Experience with content planning for a broad range of submission types across multiple stages of drug development utilizing Veeva

• Experience working with one or more Gilead TAs (Virology Inflammation and Oncology) and varying stages of drug development is strongly preferred.

Knowledge & Other Requirements

• Recognized as a SME in a broad range of regulatory submission types and a resource for technical advice and guidance.

• Able to advise cross-functional partners on technical health authority requirements and RSM processes to meet business goals and objectives.

• In-depth knowledge of relevant health authorities including system processes and regulatory requirements.

• In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products projects and markets as evidenced by effectiveness and successes with technically compliant and rapid filings.

• Knowledge of Veeva content planning and publishing best practices and tools with proven ability to apply these to improve submission efficiency and effectiveness.

• Able to advise cross-functional partners on technical health authority requirements and processes to meet business goals and objectives.

• Demonstrates strong analytical thinking skills attention-to-detail strong communication and writing skills project management skills and proficiencies with Veeva DocuBridge Microsoft Office suite Smartsheet and SharePoint as evidenced through accomplishments in past roles.

• Ability to lead and influence submissions projects and/or initiatives.

• 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.

• 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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.