Regulatory Affairs Specialist at Beacon Hill Staffing Group, LLC in Maryland Heights, Missouri

Job Description:

Summary of Position



The Regulatory Affairs Specialist responsibilities encompass the support of international drug product applications. Support of regulatory activities including but not limited to:

• 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


• Provides mentorship for entry-level regulatory associates

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


• Manage multiple priorities


• 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.


• Excellent written and oral communication skills.


• Use of software system to manage change controls.


• Strong background using Microsoft Office tools and Adobe Acrobat.


• Travel Time Required - up to 10% (May vary depending on region/site)

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.



California residents: Qualified applications 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.


If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/


Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:


Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.


Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.


Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

We look forward to working with you!


Beacon Hill. Employing the Future™
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