מדעים/ביוטק

Regulatory CMC Manager

116928

תאריך עדכון

05/02/2020

תיאור המשרה

    • Coordinate, prepare, or review regulatory submissions for development or marketed products.
    • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
    • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
    • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
    • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
    • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed drug or device changes or labeling changes.
    • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
    • Prepare or maintain technical files as necessary to obtain and sustain product approval.
    • Coordinate efforts associated with the preparation of regulatory documents or submissions.
    • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
    • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
    • Review all regulatory agency submission materials to ensure timeliness, accuracy,
    • comprehensiveness, or compliance with regulatory standards.
    • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
    • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
    • Manage activities such as audits, regulatory agency inspections, or product recalls.
    • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
    • Lead, implement and drive regional and/or global CMC strategy & submission activities, including the planning, writing, reviewing, coordination and submission of CMC sections of Briefing Packages
    • Coordinate responses to Health Authorities with appropriate personnel and departments to resolve outstanding regulatory issues
    • Develop effective proactive CMC regulatory strategies for development and marketed products
    • Represents CMC Regulatory Affairs and provide global regulatory filing strategy and guidance to interdisciplinary project teams
    • Proactively detect, inform and address potential CMC challenges for approved and development products to ensure compliance with global requirements
    •       Ensure that cross-functional CMC activities to support submissions are in compliance with regulatory requirements, to achieve timely submissions
    • Review and assess the change controls for the product under his/her responsibility to establish the regulatory impact and define the global strategy for the implementation of the changes
    • Update internal electronic systems or reviews data in such systems for regulatory information related to CMC and related activities/submission as applicable
    • Maintain thorough knowledge of the laws, regulations and guidelines covering pre and post approval CMC regulatory requirements and application maintenance
    •       Other duties as assigned or as business needs require
 
    • Requirements:
    •       Required: Bachelor's Degree in scientific field, such as chemistry, biology, pharmacy or equivalent. Preferred: Ph.D., or Master's degree
    • At least 5 years (or equivalent combination of education and related work experience) of pharmaceutical industry experience in new drug development with a significant focus on drug, biological, biosimilars and/or drug-device requirements and development strategy;
    • demonstrated working knowledge of EU and US regulations / guidance applicable to registration and approval, with proven experience in successful filing and defense of major submissions -- IND / CTA /NDA / BLA/MAA
    • Working knowledge of relevant drug and biologics regulations and guidances including ICH guidelines, GCPs, GMPs, GLPs
At least 3 years in management of CMC Regulatory Affairs activities
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