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 w