Manager, Regulatory Operations

Manager, Regulatory Operations
China - Beijing

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Job Responsibilities

• Joint responsibility for managing the Asia region within a ROW Regulatory submission publishing team. Including provision of guidance, coaching, development and performance management alongside planning and oversight of workload and resource.
• Lead and / or oversee 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.
• Maintain oversight and understanding of the regulatory environment, procedures, intelligence and submission standards. Providing guidance and interpretation of submission requirements for the Asia region.
• Provides functional and technical guidance and or training to junior colleagues or outsourcing vendor
• 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.
• 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 in Asia region submissions. Provide cross-functional education to partners in RA, CMC.
• Be a key member of the International Regulatory Operations Leadership team, helping to identify, propose, develop and manage improvement projects that align with Gilead's 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' expectations.
• The ideal candidate will align with Gilead's 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

• 8+ years of significant relevant experience and / or a BA, BS or MS.
• Experience in multiple regulatory submission publishing formats (Paper/ NeeS/ eCTD) is required.
• Experience in document processing and submission publishing of Asia countries is desirable

• Experience in China eCTD publishing testing is desirable.

• ROW
• /
• RACMC
• IRO

• WordAdobe Acrobat
• eCTD

• 8
• NeeSeCTD
• eCTD

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/China---Beijing/Manager--Regulatory-Operations_R0022061





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