Senior Manager, Regulatory Affairs

Key Responsibilities:

  • Provide input to global regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices
  • Previous experience with compilation and filing of INDs, IND amendments, NDA, NDA supplements and CTAs.
  • Represent the regulatory affairs function on project teams to provide regulatory support and advice
  • Interact with or lead corporate partners and contracted vendors regarding various regulatory matters
  • Provide support for regulatory interactions, including meetings and teleconferences with global health authorities
  • Show good judgment to determine when to escalate problems to his/her superior
  • Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function

 

  • Bachelor's degree, preferably in a scientific discipline
  • 8+ years’ experience in the pharmaceutical industry
  • 4+ years’ experience in regulatory affairs
  • Strong working knowledge of U.S. and international regulatory requirements for oncology drugs
  • Excellent oral and written communication skills
  • Ability to collaborate effectively with key stakeholders and coordinate and lead activities cross-functionally

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $137,000.00 - $189,000.00. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.​

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).

Benefits:

  • Competitive salary and annual bonus.
  • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
  • Generous parental leave and family planning benefits.
  • Outstanding culture and opportunities for personal and professional growth.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Deciphera 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.Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom.  We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.  See here for more details on our portfolio.We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:Patients – We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.Accountability – We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.Transparency – We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.Honesty and Integrity – Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.Stewardship – We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.  “How” we work together and the behaviors that we show up with each day are critical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:  Lead from where you are – regardless of role or level, we motivate each other to achieve common goals.Drive business results – we navigate forward with our eye on the highest priorities.Partner and collaborate – we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.Continuously evolve and improve – we try, we learn, we revise and try again.

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Salary
$137,000 – $189,000 per year
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