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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 marketsPlan/author/compile/submit/manage variations for marketed products outside the United States Respond to health authority information requests and comments to achieve approvalReview and assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing siteParticipate 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 requirementsMaintain 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) LSNJN-CR1_1736270767 To Apply for this Job Click Here