Regulatory Project Coordinator – 100% remote


Thousand Oaks, California

23 days ago


Similar Jobs
Regulatory Project Coordinator – 100% remote
Thousand Oaks, California

23 days ago

Job Description

Job title: Regulatory Project Coordinator – 100% remote
Duration: 5 months
Needs to support PST time zone (flexible)

Ideal candidate:
  • Someone with a mixed background not just lab but manufacturing and process development.
  • This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout the product lifecycle.
 Job Description:
  • Assist Regional Regulatory Representative in supporting regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
  • Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications.
  • Ensure compliance with submissions from regulatory agencies
  • Coordinate QC of regulatory documentation (e.g. briefing packages)
Basic Qualifications
  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
  • Assess change control records supporting ESQ areas
  • Support submissions with site related documents, as requested
  • Provide support for variation process

Note: The Company is committed to complying with the California Privacy Rights Act  (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $52.00/hr.