Sr. Manager, Regulatory CMC

Deciphera, a member of ONO, 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.  

We are seeking a Manager/Senior Manager, Regulatory CMC to join the new and growing Post-Approval Group within the larger Regulatory Affairs Organization. The primary responsibility of this position is to lead, contribute, and execute on post-approval CMC regulatory activities in support of Deciphera’s globally approved marketing applications inclusive of generating high quality and compliant CMC regulatory submissions (Module 2/Module 3) for marketing applications.

This position will report to the Associate Director, Regulatory CMC and can be performed remotely within the US.

What You’ll Do:

• Collaborate with CMC cross-functional team members to plan, write, and review CMC sections of pertinent global regulatory submissions (e.g., marketing and post-approval applications, annual reports, responses to Health Authorities).
• Provide regulatory guidance to cross-functional team members on required post-approval content of Module 2/Module 3.
• Review documentation in support of CMC and QA activities for small molecule commercial programs.
• Review and assess proposed CMC changes for global regulatory impact and post-approval filing requirements.
• Communicate with regulatory Health Authorities on project related matters as needed.
• Provide insight and guidance on implementation of current global regulations with respect to the preparation and submission of CMC regulatory documentation.

What You’ll Bring:

• B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus.
• Must have 6+ years pharmaceutical industry experience (small molecule) in CMC Regulatory Affairs. Direct experience with global commercial programs strongly preferred.
• Previous experience in either manufacturing, analytical laboratory, or GMP QA preferred.
• Experience in leading the preparation of high-quality CMC regulatory submissions (Module 2 and Module 3) for global marketing and post-approval applications.
• Strong knowledge in global regulatory (FDA, EMA, ICH) guidelines, knowledge of cGMP.
• Previous experience assessing change controls for global impact and developing regulatory strategies to implement assessed changes globally.
• Previous experience leading/supporting interactions with health authorities a plus.
• Proven ability to manage multiple projects, identify, and resolve regulatory issues.
• Attention to detail and ability to work independently as well as part of a team environment.
• Excellent organizational and communication skills, both written and verbal.
• Strong interpersonal skills and the ability to effectively work cross functionally with others.

What Deciphera will Bring:

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave
• [if applicable] Car allowance

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here. 

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.