Sr Manager, Regulatory Operations

Beijing, US
Nov 04, 2020
Required Education
Bachelors Degree
Position Type
Full time
Sr 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. Gilead’s 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 company’s five core values. That’s 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

Senior Manager - ROW Publishing Regulatory Operations

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 10,000 employees in offices across six continents. Gilead's 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 Senior Manager with unique responsibility to build a regional team within a growing, dynamic and fast paced Rest of World Regulatory Operations group. This will be the first Operations specialist based in the Asia region and represents a key milestone for the group.

With increasing speed, the concept of ROW has changed from “developing” to “emerging” to “growth” markets, with China already having become a major market. Our ROW 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 and many new countries moving towards the implementation of eCTD, this makes for a very dynamic and exciting environment with lots of opportunity for growth and development.

Job Overview / Summary

Based in the Beijing affiliate office and reporting directly to the Senior Director of International Regulatory Operations, this role will take responsibility for building a robust infrastructure to support the Asia affiliates, distribute workload globally across the US/European hubs and lead the Enterprise level initiative to prepare for eCTD implementation within China and other countries within the region. Excellent Mandarin and English language skills will be key to success in this role.

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 collect, interpret and communicate submission requirements and guidance in the Asia region to ensure we always remain compliant and fully prepared.

This exciting senior management opportunity is both strategic and operational. As a member of the International Regulatory Operations leadership team, you will be leading and / or 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, Development Systems & Process, affiliates and content authors to provide guidance on submission preparation and content.

Job Responsibilities
  • Responsibility for managing the Asia region within the 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.
  • Oversee and understand the regulatory environment, procedures, intelligence and submission standards. Providing guidance and interpretation of submission requirements for the Asia region.
  • Provide functional and technical guidance and / or training to junior colleagues in the Regulatory Operations group on submission preparation and content.
  • 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 ROW 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
  • Demonstrates an in-depth knowledge of eCTD.
  • This role requires expert knowledge of submission publishing tools and systems, Microsoft Word, Adobe Acrobat and Document Management Systems.
  • Successful candidates will be degree educated and have significant experience within a Regulatory Operations publishing environment.
  • 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 (in both English and Mandarin) 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.
  • Able to read and interpret the regulatory agency guidance on eCTD submissions

Education & Experience
  • Significant relevant 10 years of experience and / or a BA, BS or MS degree
  • Experience in regulatory eCTD submission publishing is required
  • Experience with publishing of China paper/NeeS submissions
  • People management experience is highly desirable
  • Experience in ROW Regulatory Operations is desirable

eCTD, /

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  • eCTD
  • Microsoft WordAdobe Acrobat
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  • eCTD

  • 10
  • eCTD
  • /NeeS

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