BCM ALLIANCE BERHAD is looking for new potential candidates to fill in for Group Regulatory Affairs Assistant position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
Job Duties and Tasks for: "Group Regulatory Affairs Assistant"
1) Compile and maintain regulatory documentation databases or systems.2) Coordinate efforts associated with the preparation of regulatory documents or submissions. 3) Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.4) Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.5) Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.6) Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. 7) Prepare and participate in internal or external audits.8) Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.9) Recommend changes to company procedures in response to changes in regulations or standards.10) Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.11) Write or update standard operating procedures, work instructions, or policies.12) Coordinate recall or market withdrawal activities as necessary.
Skills Needed for: "Group Regulatory Affairs Assistant"
1) Reading Comprehension -- Understanding written sentences and paragraphs in work related documents.2) Writing and communication -- Communicating effectively in writing as appropriate for the needs of the audience.3) Critical Thinking -- Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.4) Speaking -- Talking to others to convey information effectively.5) Active Listening -- 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.6) Complex Problem Solving -- Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.7) Judgment and Decision Making -- Considering the relative costs and benefits of potential actions to choose the most appropriate one.8) Systems Analysis -- Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.10) Active Learning -- Understanding the implications of new information for both current and future problem-solving and decision-making.11) Time Management -- Managing one's own time and the time of others.
Knowledge, Experience, Education Required for: "Regulatory Affairs Specialist"Language -- Knowledge of the structure and content of the English & Bahasa language including the meaning and spelling of words, rules of composition, and grammar.
BCM Alliance Berhad was incorporated in Malaysia on 13 May 2015 under the Act as a public limited company to facilitate the Listing of our Group on the ACE Market of Bursa Securities. We are an investment holding company, while our subsidiaries are principally involved in the business of supplying, installing, testing and commissioning of two product segments namely, commercial laundry equipment and medical devices.
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