Assoc Director, CMC Regulatory Affairs

Location
Foster City
Salary
See job description.
Posted
July 26 2021
Ref
R0021026
Position Type
Full Time
Organization Type
Pharma


Assoc Director, CMC Regulatory Affairs
Singapore - Singapore

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

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As Associate Director, CMC Regulatory Affairs Asia you will be either based at Gilead's Singapore office or in the US Santa Monica Headquarters. As part Kite's international CMC Regulatory Affairs team, you will lead the delivery of CMC Quality components for clinical trial applications, marketing applications and post-authorisation submissions Rest of World (RoW) countries with special focus on the Asian markets.

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day - discoveries that include our own capabilities and our individual potential.

We're currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

This position will either report to the Executive Director RA CMC who is based at Kite's Santa Monica, California, USA based corporate headquarters (if based in Santa Monica) or to the Associate Director RA CMC located in Hoofddorp, The Netherlands (if based in Singapore).

In this role you will:
  • Actively work on submissions to:
    • Ensure compliance of the CMC dossier meeting content and strategic requirements, as well as the specific local requirements of individual countries.
    • Pro-actively stay current with registration requirements in each of the applicable markets, and communicate this information to the corporation on a timely basis.
    • Contribute to and complete final review for all major and/or critical CMC submissions from marketing authorization application to post approval submissions, CMC briefing documents, requests for Scientific Advice, Drug Product Listings and Site licenses as appropriate) and CMC responses to Health Authorities
    • Ensure appropriate content and preparation of Module 1 components per market
    • Finalize CMC submission plans
    • Ensure alignment of CMC submission plans with Commercial, Clinical & IP
  • Be a key part of clear, concise timely communication:
    • Take a leadership role in updating the corporation on local or pan-regional CMC regulatory guidance and developments
    • Facilitate good communication and transparency of CMC information to relevant functions
    • Use industry network to maintain awareness of the pulse of global and local CMC best practices, and to disseminate this information to the corporation.
    • Ensure cross-regional communication and transparency in the flow of CMC information that may affect regional regulatory strategy
    • Elevate CMC issues and potential risks, along with possible resolutions, to senior management especially when such issues impact the approvability of submissions and/or product launch
  • Work as part of a global, interdepartmental team:
    • Regional lead on project and other teams in developing global CMC regulatory and change control policies and strategies
    • Provide consistent, high-quality Regulatory CMC input on CMC issues and risks along with mitigation plans/options.
  • Local Presence:
    • Build an integrated, cross functional network with in market Gilead/Kite colleagues
    • Build strong contacts with local Health Authorities and present a positive image of Kite in all discussions with Health Authorities
    • Responsible for ensuring timely discussion with Health Authorities regarding responses to questions, and will work with global colleagues to ensure consistency of responses to international Health Authorities.
  • Regulatory Strategy
    • Lead and coordinate development of regional Regulatory CMC strategy, CMC submission content and timing to ensure alignment as outlined in the global regulatory strategy document.
    • Develop CMC lifecycle management plans with input from regulatory project teams
    • Define and highlight regional/global Regulatory CMC resource issues that may affect the implementation of the Regulatory CMC strategy
    • Create an integrated global Regulatory CMC strategy based on input from the regional CMC personnel. Regional Regulatory CMC personnel are responsible for the definition of an appropriate regional regulatory strategy which is consistent with the global regulatory strategy.
    • Ensure that decisions on the global Regulatory CMC strategy are made following consultation and agreement with CMC Management and RPT.
    • Ensure that the strategy for meetings with regional regulatory authorities is consistent with the global regulatory strategy.


Your profile:
  • Advanced degree PhD and MS with strong biologics/pharmaceutical experience.
  • 10+ years experience in Regulatory Affairs, CMC
  • Direct experience working with regional CMC reviewers.
  • Regulatory Affairs Certification a plus
  • Bi or multilingual with fluency in at least one of primary regional language(s)
  • Excellent English written and oral communication skills
  • Detail oriented, self-motivated, independent and quick to adapt to changes
  • Experience in working with Asian markets and familiar with ASEAN and national requirements


As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don't miss out on this opportunity to join us and discover your sense of purpose.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Singapore---Singapore/Assoc-Director--CMC-Regulatory-Affairs_R0021026-1





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