الصفحة الرئيسية ماليزيا Manager, Regulatory Affairs
الصفحة الرئيسية ماليزيا Manager, Regulatory Affairs
Manager, Regulatory Affairs
دوام كامل
في Fresenius medical care
في
Malaysia
نُشرت يوم April 29, 2024
تفاصيل الوظيفة
Key Responsibilities / Accountabilities: Pharmacovigilance
- Collection of local AEs / ADRs
- Contact point for local regulatory authorities
- Forwarding of case reports and other important safety information to CDS
- Following up on case reports for any missing information or upon request of CDS
- E-mail or paper-based submission of ICSRs to authorities who do not allow electronic reporting (Non-EU countries)
- Quarterly reconciliation of case reports
- Screening of local literature
- PSUR submission to local authorities
- Local implementation of RMP commitments
- Local implementation of safety label changes in collaboration with CDRA
- Review of applicable local PV legislation or regulation
- Forwarding of safety relevant Health Authority requests to CDS
- Exchange of actions taken for safety reasons
- Processing of local CAPA
- Plan, review and recommend the best regulatory strategy for Pharmaceutical and medical Device submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.
- Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country’s business plan.
- Coordinates the process with other functional members of the affiliate, sites and corporate to ensure timely availability of required documents and other requirements for dossier preparation.
- Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.
- Prepare a quality regulatory dossier and submit within the planned affiliate timelines for new product submissions, line extensions, variations etc.
- Activities include: Request and obtain the various regulatory items needed for the local submission Prepare/format the dossier to ensure it meets local requirements Implement the submission and archive appropriately
- Gain Malaysia MoH approvals to meet the affiliate product launch plans and ensure product maintenance.
- Activities include: Provide quality responses to the Ministry of Health (MOH) by the due date Complete regulatory approval process and gain product licenses Communicate Product approval Archive submission dossier and approval documents Track post approval commitment, if any Perform regulatory responsibilities related packaging development Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs
- Prepare periodic Regulatory Report of actual submissions and approval
- Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements and country acts, regulations, codes, and standards or guidelines [eg. Change control for medical device, all aspects of labelling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the MoH]
- Conduct periodic compliance self-audit to identify potential compliance issues
- Perform activities related to pharmacovigilance (PhV) and materiovigilance according to Corporate and if applicable, by local regulations.
- Ensure that all functions perform in accordance with the Standard Operating Procedures to meet the Good Distribution Guidelines
- Co-ordinate the implementation and maintenance of Quality Management Systems including establishing and maintaining regulatory compliance system, coordinating management review and performing relevant audits (e.g. internal audits and vendor audits)
- Take corrective actions plans based on regulatory and pharmacovigilance audit findings
- Regulatory Customer Relations Establish relationship with key regulatory officials to influence regulators to foster positive regulatory environment for business and research.
- Regulatory Environment Changes Keep updated with current local regulations and MoH organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or affected parties.
- Influence Strategy Supports the development and implementation of the established external regulatory influence strategy.
- Trade Association- Work with Trade Associations in Malaysia on different Regulatory issues and share company position on different topics.
- Learn and understand the local affiliate organization and functions.
- Build functional partnership and credibility to maximize regulatory value in support of business decisions.
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Exchange of actions taken for safety reasons </li><li> Processing of local CAPA </li> </ul> <p> Activity </p> <p> Case management </p> <p>(ICSR collection, evaluation, safety database entry, ICSR </p> <p> reporting, reconciliation) </p> <p> Collecting and forwarding of case reports to CDS, follow-up on local reports, non-electronic expedited reporting to local health authority (Non-EU countries), quarterly reconciliation </p> <p> Management of RMPs </p> <p> Local implementation of RMP commitments </p> <p> Pre- and Post- marketing study Management </p> <p> Participation on local non-Interventional studies and forwarding of case AE/ SAE reports to Corporate Drug Safety (CDS) </p> <p> Management of Safety variations to product particulars </p> <p> Local Implementation of Label changes in close collaboration with CDRA </p> <p> Preparation PVAs </p> <p> Inform CDS about new business partners in their territory, Preparation of local PVAs </p> <p> Literature review </p> <p> Screening of Local Literature </p> <p><b>2. Regulatory Planning </b> </p> <p><u> a) Regulatory Plan Development </u> </p> <ul><li> Plan, review and recommend the best regulatory strategy for Pharmaceutical and medical Device submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes. </li><li> Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country’s business plan. </li> </ul> <p><u> b) Process Management </u> </p> <ul><li> Coordinates the process with other functional members of the affiliate, sites and corporate to ensure timely availability of required documents and other requirements for dossier preparation. </li><li> Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved. </li> </ul> <p><b>3. 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You can learn the health and safety precaution that is needed in a workplace by taking this Workplace Health & Safety Level 3 course.<br /> Employers have legal responsibilities to ensure a safe and healthy workplace. As an employee you have rights and you have responsibilities for your own well being and that of your colleagues. Your rights as an employee to work in a safe and healthy environment are given to you by law and generally can’t be changed or removed by your employer. 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Therefore it is important to exercise safety procedures in the workplace, which you can learn from this Advanced Diploma in Health and Safety.<br /> This course is divided into three sections, each focusing on helping you improve the health and safety standards in the workplace. To do this though, you need to learn the basics of health and safety, and that is exactly what the first section is about. You will look into health and safety related accidents and issues, find out about workplace hazards, understand legal aspects and find out more about RIDDOR. In the next section – titled ‘Health and Safety at Workplace’ – you find out more about a managers role, find out about different types of hazards, managing stress, and write and implement a safety plan.<br /> Finally you look into the importance of workplace safety, through learn about compulsory rules, dealing with issues and concerns, conflict resolution and so much more. This course is the ultimate guide for implementing health and safety as it cover a diverse group of topics, and you would do well to get it now.<br /> <br /> <strong>COURSE CURRICULUM<br /> <br /> Health and Safety at Workplace</strong> <ul> <li>Introduction</li> <li>Health and Safety Related Accidents and ill-health</li> <li>Legal Responsibilities and Requirements</li> <li>Managing health and safety in Workplace</li> <li>Health and Safety in The workplace</li> <li>Workplace Hazards, Slips and Trips</li> <li>General fire safety</li> <li>Work at height</li> <li>Building work</li> <li>Machinery safety</li> <li>Plant and equipment maintenance</li> <li>Workplace transport</li> <li>Lifting and handling</li> <li>Noise, Vibration</li> <li>Electricity</li> <li>Harmful substances</li> <li>Flammable and explosive substances</li> <li>Managing health, Stress and Emergency Procedures</li> <li>Role of Employer or Managers and PPE</li> </ul> <strong>Importance of Workplace Safety</strong> <ul> 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Therefore it is important to exercise safety procedures in the workplace, which you can learn from this Advanced Diploma in Health and Safety.<br /> This course is divided into three sections, each focusing on helping you improve the health and safety standards in the workplace. To do this though, you need to learn the basics of health and safety, and that is exactly what the first section is about. You will look into health and safety related accidents and issues, find out about workplace hazards, understand legal aspects and find out more about RIDDOR. In the next section – titled ‘Health and Safety at Workplace’ – you find out more about a managers role, find out about different types of hazards, managing stress, and write and implement a safety plan.<br /> Finally you look into the importance of workplace safety, through learn about compulsory rules, dealing with issues and concerns, conflict resolution and so much more. 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<li>Why Workplace Health & Safety are Important</li> <li>It Takes Team Effort!</li> <li>Some Rules are Compulsory</li> <li>Rewarding Compliance</li> <li>You Need a Backup Plan Always</li> <li>Dealing with Issues and Concerns</li> <li>How to Deal with Noncompliance</li> <li>Remember What the Workplace is for</li> <li>Make Your Workplace a Good Place</li> <li>Conflict Resolution</li> <li>Are Dress Codes Appropriate?</li> <li>Minimizing Distractions</li> <li>People Who Work After Hours</li> <li>Your Fire Safety Plan</li> <li>Being Organized</li> <li>Plan for Emergencies</li> <li>Promoting a Safe Environment</li> <li>Do You Need Security Guards?</li> <li>Special Situations: The Handicapped</li> </ul> <strong>Health and Safety at Workplace (for USA)</strong> <ul> <li>Module One – Getting Started</li> <li>Module Two – An Overview</li> <li>Module Three – Types of Hazards</li> <li>Module Four – Managers Role</li> <li>Module Five – Training</li> <li>Module Six – Stress Management</li> 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important safety information to CDS </li><li> Following up on case reports for any missing information or upon request of CDS </li><li> E-mail or paper-based submission of ICSRs to authorities who do not allow electronic reporting (Non-EU countries)</li><li> Quarterly reconciliation of case reports </li><li> Screening of local literature </li><li> PSUR submission to local authorities </li><li> Local implementation of RMP commitments </li><li> Local implementation of safety label changes in collaboration with CDRA </li><li> Review of applicable local PV legislation or regulation </li><li> Forwarding of safety relevant Health Authority requests to CDS </li><li> Exchange of actions taken for safety reasons </li><li> Processing of local CAPA </li> </ul> <p> Activity </p> <p> Case management </p> <p>(ICSR collection, evaluation, safety database entry, ICSR </p> <p> reporting, reconciliation) </p> <p> Collecting and forwarding of case reports to CDS, follow-up on local reports, non-electronic expedited reporting to local health authority (Non-EU countries), quarterly reconciliation </p> <p> Management of RMPs </p> <p> Local implementation of RMP commitments </p> <p> Pre- and Post- marketing study Management </p> <p> Participation on local non-Interventional studies and forwarding of case AE/ SAE reports to Corporate Drug Safety (CDS) </p> <p> Management of Safety variations to product particulars </p> <p> Local Implementation of Label changes in close collaboration with CDRA </p> <p> Preparation PVAs </p> <p> Inform CDS about new business partners in their territory, Preparation of local PVAs </p> <p> Literature review </p> <p> Screening of Local Literature </p> <p><b>2. Regulatory Planning </b> </p> <p><u> a) Regulatory Plan Development </u> </p> <ul><li> Plan, review and recommend the best regulatory strategy for Pharmaceutical and medical Device submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes. </li><li> Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country’s business plan. </li> </ul> <p><u> b) Process Management </u> </p> <ul><li> Coordinates the process with other functional members of the affiliate, sites and corporate to ensure timely availability of required documents and other requirements for dossier preparation. </li><li> Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved. </li> </ul> <p><b>3. Submissions and Approvals </b> </p> <p><u> a) Dossier Preparation </u> </p> <ul><li> Prepare a quality regulatory dossier and submit within the planned affiliate timelines for new product submissions, line extensions, variations etc. </li><li> Activities include: <p> Request and obtain the various regulatory items needed for the local submission </p><p> Prepare/format the dossier to ensure it meets local requirements </p><p> Implement the submission and archive appropriately </p></li> </ul> <p><u> b) Gain Regulatory Approval </u> </p> <ul><li> Gain Malaysia MoH approvals to meet the affiliate product launch plans and ensure product maintenance. </li> </ul> <ul><li> Activities include: <p> Provide quality responses to the Ministry of Health (MOH) by the due date </p><p> Complete regulatory approval process and gain product licenses </p><p> Communicate Product approval </p><p> Archive submission dossier and approval documents </p><p> Track post approval commitment, if any </p><p> Perform regulatory responsibilities related packaging development </p><p> Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs </p></li> </ul> <p><u> c) Metrics Review </u> </p> <ul><li> Prepare periodic Regulatory Report of actual submissions and approval </li> </ul> <p><b>4. 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'agencylist' => 'agencylist-critical-css', 'agencyview' => 'agencyview-critical-css', 'laimoonverified' => 'laimoonverified-critical-css', 'seopages' => 'seopages-critical-css', 'externalview' => 'externalview-critical-css', 'popularjobsearches' => 'popularjobsearches-critical-css' ) $basicProfileIncomplete = true $seeAllJobLink = 'https://jobs.laimoon.com/ar/malaysia/Manager, ' $csaKeywords = array( (int) 0 => 'Manager, Regulatory Affairs' ) $allowLoginClass = 'notlogin' $jobLocSlug = 'malaysia' $jobLocName = 'Malaysia' $pfBackgrounds = '' $jobLink = 'https://jobs.laimoon.com/jobs/externalview/43412691' $companyName = ' at fresenius medical care' $twitterText = 'Hiring now! Manager, Regulatory Affairs at fresenius medical care. Please apply or share https://jobs.laimoon.com/jobs/externalview/43412691' $emailText = 'Hiring now! Manager, Regulatory Affairs at fresenius medical care. Please apply or share by clicking here https://jobs.laimoon.com/jobs/externalview/43412691' $sCompanyName = false $csaSearchKey = 'Manager, Regulatory Affairs' $jobDetails = 'تفاصيل الوظيفة' $btn_text = 'Apply on company website' $confidentialExists = false $showCompany = (int) 1 $mainCheck = (int) 1 $confidentialThumbClass = '' $cdnImageThumbPath = 'https://cdn.laimoon.com/profileimages/thumbnail/' $companyPageTitle = 'fresenius medical care'include - APP/View/Jobs/externalview.ctp, line 206 View::_evaluate() - CORE/Cake/View/View.php, line 948 View::_render() - CORE/Cake/View/View.php, line 910 View::render() - CORE/Cake/View/View.php, line 471 Controller::render() - CORE/Cake/Controller/Controller.php, line 948 Dispatcher::_invoke() - CORE/Cake/Routing/Dispatcher.php, line 194 Dispatcher::dispatch() - CORE/Cake/Routing/Dispatcher.php, line 162 [main] - APP/webroot/index.php, line 115
الشركة المعلنة عن الوظيفة
Fresenius medical care
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