IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Senior Superintendent with Healthcare exp.

Company: Spectum Pharmaceuticals Inc.
Location: Irvine
Posted on: September 13, 2020

Job Description:

Senior Manager / Associate Director Regulatory Affairs CMC Small Molecules

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 synthetic drugs.

Identifies supporting documents required for global CMC submissions.

Authors and prepares CMC briefing documents for meetings with regulatory agencies.

Provides CMC regulatory support to project core teams.

Reviews CMC submission documents relative to regulatory guidance requirements.

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 degree preferred.

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 drug products.

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 Management Systems.


Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel:

Position is in the United States (Irvine, CA or Cambridge, MA).

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 Type Full-Time/Regular

Keywords: Spectum Pharmaceuticals Inc., Irvine , Senior Superintendent with Healthcare exp., Other , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Other Jobs

Speech Language Pathologist - Short-term (20/21 SY)
Description: We're looking for an--exceptional School Speech Language Pathologist--for a full-time position in La Mesa, CA who can start immediately and work through December 18th. This therapist will work 6.5 hours (more...)
Company: TherapyTravelers
Location: La Mesa
Posted on: 09/25/2020

Enterprise Application Specialist Sr.
Description: About The PositionReporting to the Manager, Customer Support, our team is adding an EnterpriseApplication Specialist Sr. to the team. This is an exciting opportunity toapply your senior technical knowledge (more...)
Company: Ceridian
Location: Fountain Valley
Posted on: 09/25/2020

IRB Scientific Regulatory Board Chairperson
Description: General Information Location: Cary, NC, Needham, MA, Santee, CA Organization: Western Institutional Review Board Description And Requirements We're looking for dynamic and motivated professional to join (more...)
Company: WIRB-Copernicus Group
Location: Santee
Posted on: 09/25/2020

Warehouse Team Member - Earn up to $646 a Week
Description: Warehouse Team Members Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Moreno Valley and Riverside Hourly pay rate: Earn 15/hr or more Immediate openings available now. Start as soon (more...)
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 09/25/2020

Patient Relations Coordinator
Description: Job Description Summary The Patient Relations Coordinator performs administrative and special project assignments that assure effective and efficient operations within the patient relations department. (more...)
Company: Sharp HealthCare
Location: La Mesa
Posted on: 09/25/2020

Amazon Order Picker/Packer
Description: Warehouse Team Members Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Moreno Valley and Riverside Hourly pay rate: Earn 15/hr or more Immediate openings available now. Start as soon (more...)
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 09/25/2020

Caregiver for Group Home
Description: Description Caregiver for Group Home Primary Location: United States-CA-CACarson Function: Direct Support Professional Caregivers Due to the ongoing public health concerns regarding COVID-19, as your (more...)
Company: The MENTOR Network
Location: San Gabriel
Posted on: 09/25/2020

Seasonal Amazon Package Sorter with Sign-on Bonus! (Rialto)
Description: Warehouse Team Member - Bonus Seasonal, Part-Time, Full-Time, Flexible Hours br br Shifts: br Overnight, Sunrise, Day, Evening, Weekend br br Location br Rialto br Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/25/2020

Mgr III Systems Engineering
Description: Raytheon Intelligence and Space RIS is the guiding provider of radar sensor systems. We provide war fighters the most accurate and timely information available for the network-centric battlefield. The (more...)
Company: RTX
Location: La Mirada
Posted on: 09/25/2020

Warehouse Worker - Package Handler
Description: Shift: Sunrise/Preload 4:00 AM - 9:00 AM Day 11:00 AM - 5:00 PM Twilight 5:00 PM - 11:00 PM Night 11:00 PM - 5:00 AM br --WAREHOUSE WORKER - PACKAGE HANDLERFind
Company: United Parcel Service
Location: Cerritos
Posted on: 09/25/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds