Regulatory Affairs Associate I
Company: Yoh
Location: Fremont
Posted on: October 26, 2024
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Job Description:
Regulatory Affairs Associate I External ID 33789473 Fremont, CA
- ON SITE 22 month W2 contract (with potential to extend or
transition to perm) Pay rate: $30-35/hour - Depending on Education
and Experience Summary: Shift: 1st Shift: Mon-Fri, 8:00AM-5:00PM
Responsibilities: Assist in preparing responses to global
information requests and related maintenance documentation
(amendments, supplements, annual reports, safety reports, etc.)
within a defined time schedule. Help determine regulatory
strategies for manufacturing changes and regulatory activities. Aid
in preparing Lifecycle Management like Annual Reports (Product,
DMF). Coordinate and track workflows for regulatory submissions.
Ensure regulatory submissions meet global standards. Participate in
meetings and interact with project team members and sub-teams.
Assist with and eventually lead licensing activities and required
updates (Establishment Registration, California State License,
State licensing). Support reporting requirements under the CARES
Act. Provide support to Regulatory management as needed. Skills or
Requirements: PC literacy is required. Proficiency in technology
use, including MS Office skills (Outlook, Word, Excel, PowerPoint,
MS Project). Document Management Systems and Internet resources, is
expected. General knowledge and application of global regulations
and cGMP requirements are necessary. Must be able to work
independently and with appropriate supervision. Excellent
organizational, interpersonal, and communication skills (oral and
written) are required. Education/Experience: A Bachelor's degree in
a scientific field, preferably Chemistry or Pharmacy, with 1-3
years of experience, or A Master's Degree in Regulatory Affairs
with a minimum of 3 months of regulatory experience (internship) is
required. What's In It For You? We welcome you to be a part of one
of the largest global staffing companies to meet your career
aspirations. Yoh's network of client companies has been employing
professionals like you for over 65 years in the U.S., UK and
Canada. Join Yoh's extensive talent community that will provide you
with access to Yoh's vast network of opportunities and gain access
to this exclusive opportunity available to you. Medical, Dental &
Vision Benefits 401K Retirement Saving Plan Life & Disability
Insurance Direct Deposit & weekly ePayroll Employee Discount
Programs Referral Bonus Programs Estimated Min Rate: $24.99
Estimated Max Rate: $35.70 Note: Any pay ranges displayed are
estimations. Actual pay is determined by an applicant's experience,
technical expertise, and other qualifications as listed in the job
description. All qualified applicants are welcome to apply. Yoh, a
Day & Zimmermann company, is an Equal Opportunity Employer. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
[https://www.yoh.com/applicants-with-disabilities
](https://www.yoh.com/applicants-with-disabilities) to contact us
if you are an individual with a disability and require
accommodation in the application process. For California
applicants, qualified applicants with arrest or conviction records
will be considered for employment in accordance with the Los
Angeles County Fair Chance Ordinance for Employers and the
California Fair Chance Act. All of the material job duties
described in this posting are job duties for which a criminal
history may have a direct, adverse, and negative relationship
potentially resulting in the withdrawal of a conditional offer of
employment.
Keywords: Yoh, Stockton , Regulatory Affairs Associate I, Other , Fremont, California
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