Manager Regulatory Affairs (m/f), Kota in Kota, Andhra Pradesh

Your tasks:
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
- Provide responses to regulatory agencies regarding product information or issues
- 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
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Manage activities such as audits, regulatory agency inspections, or product recalls
Your skills:
- Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action
- Understanding written sentences and paragraphs in work related documents
- Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person
- Managing one's own time and the time of others
- Communicating effectively in writing as appropriate for the needs of the audience
- Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards
- Developing constructive and cooperative working relationships with others, and maintaining them over time
- Analyzing information and evaluating results to choose the best solution and solve problems
- Observing, receiving, and otherwise obtaining information from all relevant sources
- Entering, transcribing, recording, storing, or maintaining information in written or electronic form
- Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times
Location
Kota
jobid82282
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