Associate Director, Regulatory CMC
Associate Director, Regulatory CMC
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1 Vacancy
Job Description
The Role:
We are seeking an Associate Director in Regulatory CMC who can independently lead contribute and execute on CMC regulatory activities in support of Decipheras studies across all stages of clinical drug development. The primary responsibility will be to generate high quality and compliant CMC regulatory submissions for global investigational applications initially focusing on oligonucleotide products. This position will report to the Senior Director of CMC Regulatory and will be a hybrid role based out of our Waltham MA office. Additionally opportunities will include contributing to CMC regulatory activities in support of other Deciphera small molecule and biologics programs and studies across all stages of clinical drug development.
What Youll Do:
- Collaborate with CMC crossfunctional team members to plan write and review CMC sections of pertinent regulatory submissions (e.g. global clinical trial and marketing applications briefing documents responses to Health Authorities)
- Provide regulatory guidance to crossfunctional team members on required content of Module 2/Module 3.
- Review documentation in support of CMC and QA activities for drug development programs
- Review and assess proposed CMC changes during drug development for regulatory impact and filing requirements
- Communicate with regulatory Health Authorities on project related matters
- Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation
- Review industry guidance and pharmacopoeia updates to ensure cross functional alignment with current practices and regulations
Qualifications :
- B.S. in a scientific discipline required advanced degree a plus.
- Must have at least 8 years pharmaceutical industry experience in CMC Regulatory Affairs. Direct experience with development programs through registration strongly preferred.
- Demonstrated leadership and track record of regulatory submissions including effective project management.
- Experience in preparing high quality CMC regulatory submissions (Module 2 and Module 3) for global investigational and marketing applications.
- Strong knowledge of current Good Manufacturing Practices (cGMP) biologics drug development regulations and guidelines including ICH FDA and EMA guidelines
- Knowledge of eCTD elements and structure
- Must have previous experience leading/supporting interactions with health authorities
- 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 with others
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $160000 $219000. 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 Decipheras competitive total rewards strategy that also includes annual performance bonus a longterm 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 nondiscriminatory basis.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
