Corporate Affairs Manager

Corporate Affairs Manager is managed in obtaining and maintaining government approval for drugs, medical devices and related materials
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
• Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Develop and maintain standard operating procedures or local working practices.
• Contribute to the development or implementation of business unit strategic and operating plans.
• Monitor regulatory affairs trends that are related to environmental issue
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon foot printing issues, or green policy implementation.
• Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
• Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Establish regulatory priorities or budgets and allocate resources and workloads.
• Participate in the development or implementation of clinical trial protocols.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.
• Provide responses to regulatory regarding product information or issues. Train staff in regulatory policies or procedures.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Coordinate internal discoveries and depositions with legal department staff.

Understanding legal framework applicable to pharmaceutical industry;
At least 05 years working for law firms/consulting companies or holds similar position within multinational corporations
Fluent English (4 skills)
Understanding commercial laws including contract, investment, commercial, intellectual property law (trademark law) land law, banking and labor law;

Chế độ bảo hiểm, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương

Cập nhật gần nhất lúc: 2024-04-03 10:59:30