Senior Manager / Associate Director Regulatory Affairs CMC Small
Tracking Code 734-470 Job Description Summary:
This position will support global CMC regulatory activities
related to investigational/commercial synthetic (small molecule)
drug products. This position will be responsible for preparation of
global CMC regulatory submissions including authoring the module 3
sections to achieve timely approvals.
Accountable for planning, authoring the content, and preparation
of global regulatory eCTD CMC submissions and responses to Health
Authority questions related to investigational and commercial
Identifies supporting documents required for global CMC
Authors and prepares CMC briefing documents for meetings with
Provides CMC regulatory support to project core teams.
Reviews CMC submission documents relative to regulatory guidance
Monitors, assesses, and maintains current awareness of evolving
CMC regulations and guidance documents; apprises management of the
impact of these changes.
Other activities as assigned.
Required Skills, Education and Experience:
B.S./B.A. required in Chemistry or Life Sciences; advanced
Minimum of 7 years of related experience in synthetic drug
products with strong module 3 writing experience.
Specific experience related to the preparation of global
regulatory eCTD CMC submissions for investigational and commercial
Demonstration of positive interaction skills and work ethic.
Proven communication skills (verbal and written).
Excellent organizational skills and attention to detail.
Capable of working independently and in a team environment.
Ability to manage multiple tasks simultaneously.
Ability to successfully negotiate in a team environment.
Excellent skills with MS Word, Excel, PowerPoint, and Document
Must be available to work in the evenings and weekends, as
Position Location and/or Territory and Travel:
Position is in the United States (Irvine, CA or Cambridge,
Position may require occasional travel.
Spectrum Pharmaceuticals is an equal opportunity employer, we
evaluate qualified applicants without regard to race, color,
religion, sex, national origin, disability, veteran status, and
other protected characteristics.
Job Location Irvine, CA or Cambridge, MA, United States Position