Regulatory Project Coordinator

Spectraforce

Thousand Oaks, California


a month ago

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Job Description

Title: Regulatory Project Coordinator
Location: 100% Remote
Duration: 07 Months
Minimum Pay Rate: $47 an hour 


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 to support 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.
  • Ensured compliance with submissions regulatory agencies.
  • Coordinated QC of regulatory documentation (e.g. briefing packages).
 Must-Have Qualification
  • Change Control evaluation or owner.
  • QA, Manufacturing or Operations background experience.
  • Process Development experience for biotech products.
 Education Qualification
  • Doctorate.
  • Master's degree and 3 years of experience.
  • Bachelor's degree and 5 years of experience.
  • Associate degree and 10 years of experience.
  • High school diploma / GED and 12 years of experience.
Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:
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 130 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.  Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA® with candidates and employees throughout their engagement with SPECTRAFORCE. http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers 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 nahr@spectraforce.com if you require reasonable accommodation. 

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 NAhr@spectraforce.com.