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US: Senior Manager Regulatory Affairs

Date: 27-Mar-2012
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Senior Manager Regulatory Affairs

* Proactively solicit regulatory submittals from other departments across the Company. * Assure the proper management, retention, and version control of all applicable Regulatory Affairs and product documentation including master files and amendments. * Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs. * Identify gaps and implement process improvements for daily functions, internal procedures, and regulatory agency interaction. * Interact with project team members to define submission logistics and scheduling; coordinate priorities for submissions. * Maintain a high level of expertise through reading and participation at professional seminars and workshops. * Coordinate and ensure effective and timely input into the planning, agreement and generation of required documentation, and the review and compilation of dossiers, as needed, for submission from project teams. * Evaluate and summarize requirements of applicable new regulatory guidance documents. * On an as needed basis, provide operations support regarding the development, eCTD publishing, and review of US and international regulatory submissions, i.e., INDs, CTAs, NDAs, and other applications. * Identify and clearly communicate all regulatory issues related to projects to Regulatory Management. * Independently develop regulatory strategy documents for new and/or existing projects from inception to marketing authorization, including analysis of competing products. * Bachelors’ degree in life sciences or analytical field required. * Minimum of 8 years of current regulatory affairs experience in biotech or pharmaceutical industry required. * Ability to work independently and use initiative in suggesting strategic approach to senior department management. * Demonstrated experience in IND and NDA filings. * Experience with Chemistry Manufacturing & Controls (CMC) preferred. * Direct experience preparing Clinical Trial Applications for submission in the EU. * Thorough understanding of international clinical trial and marketing authorization requirements. * Familiarity with international drug import/export requirements. * Prefer electronic DMS and filing experience. * Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate across multiple disciplines successfully and accurately, both internally and externally. * Ability to manage multiple simultaneous products/projects to meet deadlines. * Applicant must have current legal work authorization to work for any company in the United States

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