Job Description

For Current Gilead Employees and Contractors:

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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.



Founded in 1987 in Foster City, California, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 18,000 employees in offices across six continents. Gilead\xe2\x80\x99s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

We have an exciting opportunity within our Regulatory Operations team for a Manager who will be responsible for the management of a growing, dynamic, and fast paced Regulatory Operations team.

With increasing speed, the countries covered by the IC-GPS team has changed from \xe2\x80\x9cdeveloping\xe2\x80\x9d to \xe2\x80\x9cemerging\xe2\x80\x9d to \xe2\x80\x9cgrowth\xe2\x80\x9d markets. Our IC-GPS Regulatory Operations team supports submission activities for over 130 countries, spanning, Africa, Asia, Eastern Europe, EAEU, LATAM and Middle East, with a large variety of formats and requirements. Some have converted to eCTD format and with a variety of others moving towards implementation, this makes for a very dynamic and exciting environment with lots of opportunity for growth and development.

Job Overview / Summary

Based in either Cambridge or Stockley Park, this role will include the responsibilities of an established team under the oversight of a Senior Manager.

You will be managing associate level employees and this role will include but is not limited to, provision of guidance, coaching, development and performance management alongside planning and oversight of workload and resource. In addition, you will maintain oversight and interpretation of submission requirements and guidance in allocated regions and ensure we always maintain our high standards of submission.

This exciting management opportunity is both strategic and operational and as a member of the IC-GPS team, you will be performing, leading, and providing oversight for the publishing of major and or complex submissions, process development and RO systems.

You will also represent our team and / or department with external functions such as Regulatory Project Management, Regulatory Affairs, Regulatory Information Systems, affiliates and content authors to provide guidance on submission preparation and content.

Job Responsibilities

Responsibility for managing the IC-GPS Regulatory submission publishing team. Including provision of guidance, coaching, development and performance management alongside planning and oversight of workload and resource.

Perform and lead the preparation of major or complex submission compilation activities including utilization of publishing tools for electronic and paper submission generation, internal quality review and archival according to current health authority guidance, internal standards, and defined timelines.

Oversight of publishing tasks conducted by both internal staff as well as submission activity executed by outside vendors

Maintain oversight and understanding of the regulatory environment, procedures, intelligence, and submission standards. Providing guidance and interpretation of submission requirements for allocated regions.

Provides functional and technical guidance and or training to junior colleagues in the Regulatory Operations.

Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content and representing Regulatory Operations by taking the lead in submission planning meetings to help define company submission priorities.

Guides more junior colleagues on working with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content.

In addition to submission compilation activities, may lead and /or contribute with the development and management of projects and initiatives as applicable in support of Regulatory Operations.

Maintains constructive and positive interactions with colleagues.

Be a subject matter expert for IC-GPS submissions. Provide cross-functional education to partners in RA, CMC.

Be a key member of the Global Regulatory Operations Leadership team, helping to identify, propose, develop, and manage improvement projects that align with Gilead\xe2\x80\x99s global working philosophy.

Knowledge & Skills

Successful candidates will be degree educated and have significant experience within a Regulatory Operations publishing environment.

This role requires expert knowledge of submission publishing tools and systems, Microsoft Word, Adobe Acrobat and Document Management Systems.

Demonstrates an in-depth knowledge of eCTD.

Demonstrates people management skills and experience and a desire to manage the performance of more junior level individuals.

Strategic thinking is required, with a focus on process improvement and optimization.

Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.

Candidates will demonstrate an ability to balance multiple tasks to achieve goals, to meet deadlines and customers\xe2\x80\x99 expectations.

The ideal candidate will align with Gilead\xe2\x80\x99s core values by being inclusive, accountable for their work, displaying integrity in everything they do, thriving in a team environment, and seeing excellence as the only measure of success.

Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.

Demonstrates an ability to effectively communicate cross-functionally.

Education & Experience

Significant relevant experience and / or a BA, BS or MS.

Experience in regulatory submission publishing is required.

Regulatory Operations experience in numerous geographic regions is desirable

Leadership experience required

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 individual\xe2\x80\x99s 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:

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