Regulatory Affairs Specialist (Hybrid)

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Job description

Yoh is seeking a Regulatory Affairs Specialist for our Pharmaceutical client here in St. Louis, Missouri. This individual will need to have a strong manufacturing regulatory background and experienced in planning and authoring pharmaceutical documents. The position does offer a hybrid schedule and a chance to joining a growing company.

Position Type: Hybrid
Rate: $30-$34/hr.
Hours: 8:00 am - 5:00 pm

Position Summary:

• Plan/author/compile drug product dossiers in CTD format for expansion to international markets
• Plan/author/compile/submit/manage variations for marketed products outside the United States
• Respond to health authority information requests and comments to achieve approval
• Review and assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
• Participate in cross-functional teams and provide health authority requirements needed for support of initial international filings and post-approval changes
• Facilitate the creation of foreign language labeling content to meet local health authority requirements
• Maintain regulatory knowledge of current guidelines and regulations.
• Maintain current regulatory databases and produce various reports as needed.

Essential Functions

• Authoring, organization, and preparation of CTD regulatory filings; also includes peer review of filings.
• Understand, identify potential regulatory risks, and recommend strategies based on current ICH and health authority requirements
• Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
• Process, interpret, and provide recommendations for complex, unusual issues.
• Critically review documentation for regulatory submissions and provide input for necessary revisions.

Requirements

• Bachelor Degree in scientific discipline required or equivalent work experience.
• 3 or more years of Regulatory experience or related field required.
• Self-starter who takes initiative to learn, grow and excel as a Regulatory Affairs professional.
• Background in manufacturing, research and development, or quality assurance sufficient to understand how products are produced and marketed.
• Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
• Cross-functional interaction experience, coordinating activities, driving assigned submissions to completion, and working to align communications with other departments is required.

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.

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