Regulatory Affairs Specialist

Overview

Yoh is hiring a Regulatory Affairs Specialist for our Pharmaceutical Manufacturing client in St. Louis, MO
.

Position Summary:

• Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
• Assist with CMC regulatory impact regulatory strategy for post-approval changes proposed at the manufacturing site
• Preparation information and technical data needed for support of post-approval changes
• Author/review updates to marketed product labeling

Job Functions:

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Authoring, organization, and preparation of electronic regulatory filings; also includes peer review of filings
• Assist with identification of potential regulatory risks and recommended strategies based on current FDA/health authority requirements
• Critically review documentation for regulatory submissions and provide input for necessary revisions.

Education/Experience

Required:

• Bachelor Degree in Scientific field required or equivalent work experience.
• Knowledgeable ofUS and International regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Minimum of 1-2 years of Regulatory experience.
• Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required.

#IND-SPG

Estimated Min Rate
: $30.00

Estimated Max Rate
: $35.00

We welcome you to be a part of the largest and legendary 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.

Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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