Regulatory Affairs Director

Foster City
See job description.
October 12 2021
Other, Other
Position Type
Full Time
Organization Type
Job Type

Regulatory Affairs Director
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

  • Managing a team, focused primarily on Gilead's new and existing Liver & Anti-fungal therapeutic areas
  • Timely and compliant filing of regulatory dossiers including clinical trial applications, amendments and other clinical trials submissions
  • Managing Marketing Authorisation (MA) applications, Variations and other MA maintenance applications.
  • Interaction with regulatory agencies for rapid approvals with competitive labelling.
  • Representing regulatory and contributing to the brand cross-functional team, conducting promotional material review and ensuring core claims are compliant with the licence.
  • Managing the NMPA approval of Risk Minimization materials.
  • Promoting the China business needs in China strategies on drug development.
  • Where applicable supporting Expanded access schemes: Compassionate Use/Early Access applications/Named patient.
  • Actively participate in internal working groups, and assuming systems responsibility for key regulatory systems.
  • Maintains up to date knowledge of highly complex regulatory requirements, contributes to preparation of new local regulatory guidance when applicable.
  • Closely monitor report relevant changes to local requirements and competitor regulatory information to International Regulatory, Regulatory Intelligence and the local Affiliate.
  • Act as a back-up for Regulatory Affairs Senior Director at NMPA inspections and internal Audits.

The Individual

Your skills and qualifications will ideally include:
  • Extensive experience in regulatory affairs.
  • Life sciences degree and Masters in regulatory affairs (or appropriate professional qualifications)

What we will be looking for in you:
  • You will be flexible and proactive with strong influencing and negotiation skills.
  • Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
  • Accomplished at building strong working relationships, you will enjoy working in cross-functional teams across the organisation
  • Strong line management skills and experience of managing teams
  • Excellent decision making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
  • Excellent verbal, written, organization skills and interpersonal communication skills

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For Current Gilead Employees and Contractors:

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