Manager, Regulatory Affairs
Full time
at Fresenius medical care
in
Malaysia
Posted on April 29, 2024
Job details
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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The professional balancing of ice cream recipes course covers all the essential skills and knowledge needed to become specialized in this sector. You will learn real life knowledge and expertise from the industry experts and practitioners from this The professional balancing of ice cream recipes course.<br> <br> <strong>The professional balancing of ice cream recipes</strong> Course starts with the basic knowledge of The professional balancing of ice cream recipes and gradually shares expertise knowledge. In this course you will get a complete idea of The professional balancing of ice cream recipes with key concepts, strategies regarding use of it and in-depth knowledge. <strong>The professional balancing of ice cream recipes</strong> course is completely an online course. You can access this course from any part of the world with just a smart device and the internet.<br> <br> By the end of this course, you will get complete knowledge and marketable skills. The course also comes with an E-certificate, which will add extra value to your resume and help you stand out in the job market. In short, The professional balancing of ice cream recipes Course is the perfect course to fast track your career. So what are you waiting for? Enroll today!<br> <br> <strong>What you will learn</strong> <ul> <li>How to read, interpretate, modify and write an artisanal ice-cream recipe</li> <li>Which re the technical functions of te ice-cream ingredients</li> </ul> <strong>Who is this course for?</strong><br> This course is ideal for those who work in or aspire to work in the following professions: <ul> <li>Ice cream makers, ice cream artisans, pastry chefs.</li> </ul> <br> <strong>Why Choose The professional balancing of ice cream recipes course?</strong> <ul> <li>Conducted by industry experts</li> <li>Get Instant E-certificate</li> <li>Fully online, interactive course with Professional voice-over</li> <li>Developed by qualified professionals</li> <li>Self paced learning and laptop, tablet, smartphone friendly</li> <li>Tutor Support</li> </ul> <br> <strong>Certification</strong><br> By the successful completion of the course, you will get an instant e-certificate. 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The PAT Training course is exactly what you need! <br /> <br /> Without <strong>PAT testing</strong>, it gets tough to detect electrical defects with naked eyes! It is also essential to know about PAT because you will protect yourself and the people around you from dangerous accidents like an electric shock, fire, and other hazards! <br /> <br /> With the PAT Training course, you will learn about portable electrical appliances, PAT testing, reducing and controlling risks, instruments testing and equipment inspection, safety precautions, and much more! This course will further teach you how to perform a risk assessment ;<br /> <br /> The PAT Training course will give you insights on everything about PAT, which will enhance your chances in the relatable career path, and you will also be able to implement your learnings in the right way when needed! <br /> <br /> Electrical hazards and fire can be hazardous and fatal. And that’s why to overcome the fatal situations; the PAT Training course will teach you about the inspection and testing procedures so that you do not make any mistakes! With that being said, you should know that It’s better to be safe rather than being sorry!<br /> <br /> Hurry up now!<br /> <br /> <strong>Enroll immediately</strong>!<br /> <br /> <br /> <em>This PAT Training Course Package Includes</em> <ul> <li>FREE PDF and Hard Copy Certificate in ZERO Expenditure</li> <li>Comprehensive lessons and training provided by experts on PAT Training</li> <li>Interactive online learning experience provided by qualified professionals at your convenience </li> <li>24/7 Access to the course materials and learner assistance </li> <li>Easy accessibility from any smart device (Laptop, Tablet, Smartphone, etc.)</li> <li>A happy and handy learning experience for the professionals and students</li> <li>100% learning satisfaction, guaranteed by Compliance Central — a leading compliance training provider approved by National Safety Council, IAO & ROSPA</li> </ul> <strong>Who Should Take the Course</strong><br /> <br /> This course is for all the individuals working with electrical appliances and want to learn about PAT ;<br /> <br /> However, the list below are examples of people who should take this course: <ul> <li><strong>Electricians</strong></li> <li><strong>Landlord</strong></li> <li><strong>People working with electrical appliances</strong></li> </ul> <br /> <strong>Assessment: </strong><br /> <br /> Complete this <strong>PAT Training</strong> course and sit up for a short online assessment to instantly evaluate your understanding of the subject. 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<li>Equipment testing instruments </li> <li>In-service inspection and testing </li> <li>Electrical installation testing, safety precautions in electrical testing </li> <li>Reporting and record-keeping </li> </ul> <br /> <strong>Course Overview:</strong><br /> <br /> If you are here to know more about <strong>PAT</strong> and to ensure safety standards when using electrical appliances then you have come to the right place! The PAT Training course is exactly what you need! <br /> <br /> Without <strong>PAT testing</strong>, it gets tough to detect electrical defects with naked eyes! It is also essential to know about PAT because you will protect yourself and the people around you from dangerous accidents like an electric shock, fire, and other hazards! <br /> <br /> With the PAT Training course, you will learn about portable electrical appliances, PAT testing, reducing and controlling risks, instruments testing and equipment inspection, safety precautions, and much more! This course will further teach you how to perform a risk assessment ;<br /> <br /> The PAT Training course will give you insights on everything about PAT, which will enhance your chances in the relatable career path, and you will also be able to implement your learnings in the right way when needed! <br /> <br /> Electrical hazards and fire can be hazardous and fatal. And that’s why to overcome the fatal situations; the PAT Training course will teach you about the inspection and testing procedures so that you do not make any mistakes! With that being said, you should know that It’s better to be safe rather than being sorry!<br /> <br /> Hurry up now!<br /> <br /> <strong>Enroll immediately</strong>!<br /> <br /> <br /> <em>This PAT Training Course Package Includes</em> <ul> <li>FREE PDF and Hard Copy Certificate in ZERO Expenditure</li> <li>Comprehensive lessons and training provided by experts on PAT Training</li> <li>Interactive online learning experience provided by qualified professionals at your convenience </li> <li>24/7 Access to the course materials and learner assistance </li> <li>Easy accessibility from any smart device (Laptop, Tablet, Smartphone, etc.)</li> <li>A happy and handy learning experience for the professionals and students</li> <li>100% learning satisfaction, guaranteed by Compliance Central — a leading compliance training provider approved by National Safety Council, IAO & ROSPA</li> </ul> <strong>Who Should Take the Course</strong><br /> <br /> This course is for all the individuals working with electrical appliances and want to learn about PAT ;<br /> <br /> However, the list below are examples of people who should take this course: <ul> <li><strong>Electricians</strong></li> <li><strong>Landlord</strong></li> <li><strong>People working with electrical appliances</strong></li> </ul> <br /> <strong>Assessment: </strong><br /> <br /> Complete this <strong>PAT Training</strong> course and sit up for a short online assessment to instantly evaluate your understanding of the subject. The test will be an automated one, your answers will be checked and reviewed then and there, and you’ll get unlimited chances to retake the exam! <br /> <br /> Our concern is to make you competent for the job that is why you get full support from our part to learn and understand it thoroughly. The test fees are included in the one-time paid course fee. 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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. 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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Fresenius medical care
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