Director, EU Regulatory Affairs

☞ Deciphera Pharmaceuticals

전망: 174

갱신일: 29-03-2024

위치: Zug Zug ZG

범주: 과학 노동

산업: Pharmaceutical Manufacturing

수평: Director

직업 종류: Full-time

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작업 내용

Company DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.Accountability – for our performance and the way we work with coworkers and other stakeholders.Transparency – in our intent and actions to both internal and external stakeholders.Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.Stewardship – values and uses wisely the resources and investments provided to the company.Job DescriptionThis role provides an opportunity for the EU Director of Regulatory Affairs to lead the regulatory organization in EU. This position will be highly encouraged to mentor and share EU best practices with the global teams and have access to support from the global teams to execute important EU regulatory work across programs.The RoleThe Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies in EU across the product pipeline.This position will report to the Vice President of Regulatory Affairs.What You’ll Do
  • Working as the EU regulatory lead responsible for the strategic regulatory development of oncology programs (ranging from FIH through post-marketing stage)
  • Serve as EU leader for regulatory organization and liaison to EU business and medical colleagues
  • Address complex issues by providing solid regulatory solutions and guidance to the cross-functional teams and senior management
  • Monitor global regulatory changes that may impact asset development and participate in business development activities relevant to EU to drive program forward
  • Ensure compliance of regulatory strategies and submissions and management of vendors supporting activities in EU
  • Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company both globally and locally to EU
  • While there is a strong preference for Zug, other locations within Europe will be considered.
Qualifications
  • B.S/M.S. and 8+ years of work experience in pharmaceutical regulatory affairs
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU
  • Must have experience engaging directly with EMA and highly desirable to additionally be experience in working with SwissMedic and MHRA
Preferred Qualifications
  • Capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Demonstrates excellent verbal and written communication skills
Additional InformationWhat Deciphera will Bring:Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:
  • Summer vacation bonus
  • Global, company-wide summer and winter shutdowns
  • An annual lifestyle allowance
  • Internal rewards and recognition program
Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.
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마감 시간: 13-05-2024

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