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.
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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 .
