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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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