Job Description

We are seeking a Manager, Regulatory Affairs – 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 OF CMC REGULATORY and will be located in the Waltham, MA office.

KEY RESPONSIBILITIES 

• 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.

Qualifications

• B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus.
• Must have 3-5 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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.