Manager, Regulatory Affairs
Full time
na Fresenius medical care
no
Malaysia
Publicado em April 29, 2024
Detalhes do emprego
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 don't have to sit in a stuffy classroom for four days and drink horrible coffee while eating stale sandwiches. Your online course will enable to you get on with your schedule AND take the course. It's less expensive too which is nice for those who need to manage their budgets.<br></p><ul><li>100% Pass Rate! </li><li>Full tutor support included </li><li>Study at your own pace </li><li>100% Money Back Guaranteed!</li></ul><p><strong>IOSH Managing Safely Course Overview</strong></p><ul><li><strong>Assessing Risks</strong> - Risk assessments and a simple scoring system are introduced in this module, and delegates are given the chance to execute both.</li><li><strong>Investigating Accidents And Incidents</strong> - This sheds light on the importance of determining the "path" of workplace accidents, and how to properly go about it.</li><li><strong>Identifying Hazards</strong> - This is where all main issues of any operation are tackled - everything from entrances and exits, to work traffic, to fire, to chemicals, electricity, and so much more are discussed.</li><li><strong>Measuring Performance</strong> - This explains how checking performance contributes to the improvement of health and safety in a work environment through basic performance indicators, auditing, and proactive and reactive measuring.</li><li><strong>Understanding Your Responsibilities </strong> - This module rounds up the demands of the law and how the legal system works in reinforcing a health and safety management system.</li><li><strong>Controlling Risks</strong> - This examines how risks can be fully controlled or reduced through specific techniques and methods.</li><li><strong>Protecting Our Environment</strong> - This module provides a comprehensive introduction to the value of environmental responsibility of operations and how managers have the power to minimise environmental impacts.</li><li><strong>Introducing Managing Safely</strong> - This module reinforces the role of managers in making sure all members of their team understand the significance and uphold the principles of managing safely.</li></ul><p><strong>What's included in this course? </strong></p><p>The pricing indicated on this page includes the course, examination, and certificate fees. 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You don't have to sit in a stuffy classroom for four days and drink horrible coffee while eating stale sandwiches. Your online course will enable to you get on with your schedule AND take the course. It's less expensive too which is nice for those who need to manage their budgets.<br></p><ul><li>100% Pass Rate! </li><li>Full tutor support included </li><li>Study at your own pace </li><li>100% Money Back Guaranteed!</li></ul><p><strong>IOSH Managing Safely Course Overview</strong></p><ul><li><strong>Assessing Risks</strong> - Risk assessments and a simple scoring system are introduced in this module, and delegates are given the chance to execute both.</li><li><strong>Investigating Accidents And Incidents</strong> - This sheds light on the importance of determining the "path" of workplace accidents, and how to properly go about it.</li><li><strong>Identifying Hazards</strong> - This is where all main issues of any operation are tackled - everything from entrances and exits, to work traffic, to fire, to chemicals, electricity, and so much more are discussed.</li><li><strong>Measuring Performance</strong> - This explains how checking performance contributes to the improvement of health and safety in a work environment through basic performance indicators, auditing, and proactive and reactive measuring.</li><li><strong>Understanding Your Responsibilities </strong> - This module rounds up the demands of the law and how the legal system works in reinforcing a health and safety management system.</li><li><strong>Controlling Risks</strong> - This examines how risks can be fully controlled or reduced through specific techniques and methods.</li><li><strong>Protecting Our Environment</strong> - This module provides a comprehensive introduction to the value of environmental responsibility of operations and how managers have the power to minimise environmental impacts.</li><li><strong>Introducing Managing Safely</strong> - This module reinforces the role of managers in making sure all members of their team understand the significance and uphold the principles of managing safely.</li></ul><p><strong>What's included in this course? </strong></p><p>The pricing indicated on this page includes the course, examination, and certificate fees. Upon successful completion, the certificate will be issued by IOSH (Institution of Occupational Safety and Health), will then be posted to us, and will be delivered to your location, from the UK. VAT charges (excluded in the price) will only apply for UK/EU based students. </p><br><p><strong>Frequently Asked Questions</strong></p><p><strong>1. What is the IOSH Managing Safely eLearning Course?</strong></p><p>The IOSH Managing Safely eLearning course is the perfect way for you to gain this highly respected certificate in the comfort of you own home or office. Your course is entirely online which mean you don't have to travel to a training venue. This helps save time and money! </p><p><strong>This online course is the EXACT same course as the classroom taught course. As a matter of fact, the certificate you will receive after you pass the course is the same as well.</strong></p><p><strong>2. 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In this course you will learn how: <br /> <br /> Forensic science developed and its roles in police work and solving crimes<br /> Evidence such as blood and fingerprints can be analyzed and used as evidence<br /> To determine how long someone has been dead, even for a very long time<br /> Powerful DNA evidence is to catch a criminal<br /> Forensic scientists apply their expertise in court<br /> Forensic scientists work in different roles and settings<br /> <br /> With this course, you will gain a good understanding of what Forensic Science is, the basic principles that are applied, and the different techniques and technologies that are used in the process.<br /> </p><h4>Course for?</h4><p>Do you want the opportunity to know more, or start a new career, a career that allows you to help solve crimes?<br /> Not only will our online Forensic Science course equip you with a new wealth of knowledge to prepare you for a new career, improve your current job, enhance your resume, or help you understand your favorite crime book or TV show better, but it will also allow you to do all of your studies on your own time, from home.<br /> Whether you need a new challenge, are looking to gain experience in an interesting and exciting field, or simply to know more about it, learning about Forensic Science is a great way to improve your opportunities and personal satisfaction. </p><h4>Requirements</h4><p>International Open Academy courses are designed for anyone with an interest in learning. 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Other crimes are more complex to solve and require forensic evidence to identify and prove the perpetrator's guilt.<br /> Forensic science has become the modern "smoking gun" to help solve many of these cases. Perhaps you've been watching too many CSI shows on TV and you've been wondering if all their techniques are real? Maybe you are interested to know how basic principles of science can be used in crime investigation, are considering a career as a forensic scientist, or need to know more to advance your current field, such as criminology, forensic psychology, criminal law, or crime-writing?<br /> If your answer "yes" to any of these questions, our online Forensic Science course is uniquely designed for individuals like you, who: <br /> <br /> Have an interesting in science<br /> Have a passion for solving crimes and justice<br /> Enjoy obtaining new knowledge<br /> Want a better understanding of criminal investigations and court cases<br /> Are considering a new career or want to enhance your current career<br /> Would like to have an impressive addition to your resume<br /> </p><h4>What you will learn</h4><p>Throughout our online curriculum you will learn the basics of the forensic sciences, from principles to analytical techniques that are used to build information useful in solving crimes. The contributions in the criminal justice system are unmeasurable. For instance, DNA evidence has been the reason that more than 300 prisoners, many on death row, have been exonerated, some after decades in prison. In this course you will learn how: <br /> <br /> Forensic science developed and its roles in police work and solving crimes<br /> Evidence such as blood and fingerprints can be analyzed and used as evidence<br /> To determine how long someone has been dead, even for a very long time<br /> Powerful DNA evidence is to catch a criminal<br /> Forensic scientists apply their expertise in court<br /> Forensic scientists work in different roles and settings<br /> <br /> With this course, you will gain a good understanding of what Forensic Science is, the basic principles that are applied, and the different techniques and technologies that are used in the process.<br /> </p><h4>Course for?</h4><p>Do you want the opportunity to know more, or start a new career, a career that allows you to help solve crimes?<br /> Not only will our online Forensic Science course equip you with a new wealth of knowledge to prepare you for a new career, improve your current job, enhance your resume, or help you understand your favorite crime book or TV show better, but it will also allow you to do all of your studies on your own time, from home.<br /> Whether you need a new challenge, are looking to gain experience in an interesting and exciting field, or simply to know more about it, learning about Forensic Science is a great way to improve your opportunities and personal satisfaction. </p><h4>Requirements</h4><p>International Open Academy courses are designed for anyone with an interest in learning. 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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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Fresenius medical care
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IOSH Managing Safely Wise Global Training LtdAED 1,161
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https://my.jooble.org/external/4738821711906095478?cpc=d0FU&utm_source=affiliate&utm_medium=laimoon_organic_my&extra_ars_request_id=2a17458b2c7e918d11efc10e59bd2196