Regulatory Affairs Associate I

Yoh • Contract with Option to Extend • California, Fremont, United States • 6h ago

Regulatory Affairs Associate I
External ID #
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 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.