Manager Senior Manager Regulatory Affairs Submissions Apply
Manager/Sr Manager, Regulatory Affairs (Submissions)
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Department: Regulatory Affairs & QA
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Supervisor: VP RA&QA
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QUALIFICATIONS:
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Education:
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§ Minimum BA/BS or equivalent work experience in life science or closely related
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field.
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Professional
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Experience:
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§ Minimum of five (5) years overall experience in the pharmaceutical industry.
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§ Minimum of three (3) years direct experience with regulatory submissions.
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Knowledge and
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Skills:
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§ Proven project management skills; ability to multi-task, meet deadlines as well as
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coach colleagues to meet deadlines
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§ Working knowledge of computer software, including advanced MS Word features.
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§ Experience with publishing tools and electronic document management systems
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as used within the pharmaceutical industry.
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§ Strong problem solving skills. Ability to manage tasks with clear objectives/goals,
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measures, process, progress, and results with attention to detail.
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§ Strong interpersonal, communication and influencing skills and ability to
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collaborate effectively with other groups in a matrix organization.
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POSITION OVERVIEW/SUMMARY:
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The Manager, Regulatory Affairs (Submissions) contributes to the strategic planning and preparation of
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regulatory submissions and supports the formatting, organization, and structuring of major regulatory
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submissions for his/her assigned products and/or therapeutic area(s) in collaboration with other departmental
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representatives.
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The Manager, RA (Submissions) is responsible for the scheduling, timelines, follow-up, and preparation of all
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IND/NDA Annual Reports, Amendments, Briefing Documents and other periodic submissions in support of
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regulatory filings to regulatory agencies. Working closely with intra-departmental and cross-functional teams,
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he/she serves as an internal project manager for the submissions process to ensure that submissions are
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prepared in a compliant, high-quality fashion and within assigned timelines. The incumbent also oversees the
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document acquisition process and storage/filing of draft and final documents.
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KEY RESPONSIBILITIES:
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§ Prepares (e.g.: compile, organize, assembly, and transcribe) applicable information and data for IND and/or
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NDA applications, Amendments, Supplements, Safety Reports, Annual Reports, Agency meeting/briefing
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documents and general correspondence for all assigned clinical development and/or marketed products
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for submission to regulatory agencies.
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§ Provides guidance and support for organization, formatting, and structure of assigned regulatory
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submissions (IND, NDA) for assigned products and/or therapeutic area(s).
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§ Member Clinical Operations Team(COT) representing Regulatory Affairs.
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§ Manages the internal submissions process:
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▬ Tracks and monitors all submissions in-progress
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▬ Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of
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major regulatory submissions.
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▬ Acts as contact for collection of required documents from participating departments, and distribution of
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those documents for review and approval by Regulatory Affairs management.
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▬ Provides regulatory support to other departments and multi-functional teams to ensure
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compliance with regulatory requirements for content and format of paper/electronic regulatory
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submissions and documentation.
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▬ Ensures the accuracy and completeness of electronic and hard copy regulatory files.
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▬ Provides support during interactions with regulatory agencies reviewing submission content.
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▬ Coordinates and prepares SPL submissions as required.
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§ Contributes to process improvement initiatives across the organization.
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§ Assists with other regulatory activities and special projects as required.
