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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'0', 'timing' => '', 'location' => 'Online', 'global_location_id' => '275', 'school' => 'Phoenix Health & Safety', 'logo' => '', 'certificate_diploma' => 'yes', 'image' => '', 'brochure_url' => '', 'video' => '', 'cost' => '', 'price' => '85', 'price_enquiry' => '0', 'course_status' => 'Paid', 'base_price' => '115', 'nondiscounted_base_price' => '133', 'currency' => 'GBP', 'discount' => '55% off through Laimoon!', 'free_trial_text' => '', 'laimoon_offer' => '1', 'summary' => '<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. This also includes 3 months of tutor and admin support. VAT charges (excluded in the price) will apply for UK based students. </p><p><strong>Why should you consider taking IOSH online? </strong></p><p>An IOSH e-learning certification is worth the same as a classroom-based qualification. In fact, the certificate you receive at the end of your course won't even mention the method of study. You can start at your own schedule, without having to leave the comfort of your own home. In addition, taking the course online is more affordable than taking it on a typical classroom-based setup. </p><p><strong>Course Overview</strong></p><br><p>The IOSH Working Safely Online course is suitable for any worker in any industry. Nationally recognised and respected, it is aimed at people at all levels and it meets the government's guidelines for introductory health and safety training. This e-learning course aims to ensure that delegates appreciate the importance of risk management and know how to make a difference to the health, safety and wellbeing of themselves and others by changing their behaviour.</p><p><strong>Programme</strong></p><ul><li>Module 1: Introducing working safely </li><li>Module 2: Defining hazard and risk </li><li>Module 3: Identifying common hazards </li><li>Module 4: Improving safety performance </li><li>Module 5: Protecting our environment</li></ul><p><strong>Study Method</strong></p><p>The IOSH Working Safely online course allows you to study when and where you wish, and at your own pace. Our online system is available 24 hours a day, 7 days a week. The system is easy to use, with clear navigation menus and structure. </p><p>The course can be taken on your PC, Mac, Tablet or Smartphone. You can resume your learning from any device at any time. </p><p>The training programme is highly interactive and it includes a range of activities and quizzes to help review and reinforce learning. We also provide mock assessments that are marked automatically, meaning you benefit from instant feedback. These tests help you to practice for your final assessments. </p><p>Each module of the Working Safely course includes the following elements: </p><ul><li>Required learning outcomes - an overview of the module and what should be learnt </li><li>Videos and animations to bring the learning to life </li><li>Additional support materials </li><li>Interactive learning and review exercises </li><li>Links to additional supplementary reference materials and legislation</li></ul><p><strong>Support</strong></p><p>Our expert tutors are on hand to provide full support for the duration of your course. They can be contacted by phone, email, Skype or via our technical tutor support messaging system. </p><p><strong>Certification </strong></p><p>There are two assessment elements to this course and delegates must complete both in order to receive the relevant certificate. These elements are a final multiple choice assessment and a hazard spotting exercise. Both assessments are automatically marked and immediate feedback given on results. </p><p>Learners should aim to complete their study hours, exercises and assessments within one month of starting the course. Note that registration with IOSH is restricted to three months from purchase. This allows time for one resit, the cost of which is included within the price of the online course. After this three-month period has elapsed, students may be subject to re-registration fees.</p><p><strong>Cancellation Policy</strong></p><p>For this course, exam, and certification package, no refunds or cancellations can be offered once login and access details have been provided, as a third party awarding body (IOSH) is involved in the certification process.</p><p><strong>Phoenix Health & Safety Pass Pledge </strong></p><p>Phoenix Health & Safety offer a pass pledge on all IOSH courses. This means that candidates are entitled to continue studying (free of charge) if they fail to meet the required standard in the examinations. </p><p>We're confident that you'll pass the course first time and we have a range of revision materials to help with your studies, as well as audio books and supportive Facebook groups.</p>', 'outline' => '', 'who_should_take_this_course' => '', 'eligibility' => 'The IOSH Working Safely Online course is suitable for any worker in any industry. 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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. This also includes 3 months of tutor and admin support. VAT charges (excluded in the price) will apply for UK based students. </p><p><strong>Why should you consider taking IOSH online? </strong></p><p>An IOSH e-learning certification is worth the same as a classroom-based qualification. In fact, the certificate you receive at the end of your course won't even mention the method of study. You can start at your own schedule, without having to leave the comfort of your own home. In addition, taking the course online is more affordable than taking it on a typical classroom-based setup. </p><p><strong>Course Overview</strong></p><br><p>The IOSH Working Safely Online course is suitable for any worker in any industry. Nationally recognised and respected, it is aimed at people at all levels and it meets the government's guidelines for introductory health and safety training. This e-learning course aims to ensure that delegates appreciate the importance of risk management and know how to make a difference to the health, safety and wellbeing of themselves and others by changing their behaviour.</p><p><strong>Programme</strong></p><ul><li>Module 1: Introducing working safely </li><li>Module 2: Defining hazard and risk </li><li>Module 3: Identifying common hazards </li><li>Module 4: Improving safety performance </li><li>Module 5: Protecting our environment</li></ul><p><strong>Study Method</strong></p><p>The IOSH Working Safely online course allows you to study when and where you wish, and at your own pace. Our online system is available 24 hours a day, 7 days a week. The system is easy to use, with clear navigation menus and structure. </p><p>The course can be taken on your PC, Mac, Tablet or Smartphone. You can resume your learning from any device at any time. </p><p>The training programme is highly interactive and it includes a range of activities and quizzes to help review and reinforce learning. We also provide mock assessments that are marked automatically, meaning you benefit from instant feedback. These tests help you to practice for your final assessments. </p><p>Each module of the Working Safely course includes the following elements: </p><ul><li>Required learning outcomes - an overview of the module and what should be learnt </li><li>Videos and animations to bring the learning to life </li><li>Additional support materials </li><li>Interactive learning and review exercises </li><li>Links to additional supplementary reference materials and legislation</li></ul><p><strong>Support</strong></p><p>Our expert tutors are on hand to provide full support for the duration of your course. They can be contacted by phone, email, Skype or via our technical tutor support messaging system. </p><p><strong>Certification </strong></p><p>There are two assessment elements to this course and delegates must complete both in order to receive the relevant certificate. These elements are a final multiple choice assessment and a hazard spotting exercise. 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The online course aims to equip managers and supervisors with the skills and know-how to evaluate their organisation's safety systems, identify areas for improvement and implement new control measures to reduce risk when appropriate.</p><p><strong>Programme</strong></p><ul><li>Module 1 - Introducing managing safely <br></li><li>Module 2 - Assessing risks <br></li><li>Module 3 - Controlling risks <br></li><li>Module 4 - Understanding responsibilities <br></li><li>Module 5 - Understanding hazards <br></li><li>Module 6 - Investigating Incidents <br></li><li>Module 7 - Measuring Performance<br></li></ul><p><strong>Study Method</strong></p><p>Rather than being tied down to a classroom schedule, candidates can access our e-learning courses 24 hours a day, seven days a week. This added flexibility means you can study at a time and place that suits you. </p><p>Each user has easy log in access to their own secure learning account. The online learning system is extremely user-friendly, and can be accessed on computer, tablet and/or smartphone. No matter what device users log in with, they are able to resume their learning at any time, from any device.</p><p>Each individual module includes:</p><ul><li>Learning objectives, with an overview of the module and what is required <br></li><li>All required course learning content <br></li><li>Short films and video clips <br></li><li>Interactive revision exercises and learning activities <br></li><li>Links to further reading and additional reference materials<br></li></ul><p><strong>Support</strong></p><p>Our team of expert mentors will be available to offer full learning support throughout the duration of the course. 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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. This course also includes six months of mentor and admin support. VAT charges (excluded in the price) will apply for UK based students. </p><p><strong>Why should you consider taking IOSH online?</strong></p><p>An IOSH e-learning certification is worth the same as a classroom-based qualification. In fact, the certificate you receive at the end of your course won't even mention the method of study. You can start at your own schedule, without having to leave the comfort of your own home. In addition, taking the course online is more affordable than taking it on a typical classroom-based setup.</p><p><strong>Course Overview</strong></p><p>The IOSH Managing Safely qualification is intended for those who have health and safety management responsibilities in the workplace. The online course aims to equip managers and supervisors with the skills and know-how to evaluate their organisation's safety systems, identify areas for improvement and implement new control measures to reduce risk when appropriate.</p><p><strong>Programme</strong></p><ul><li>Module 1 - Introducing managing safely <br></li><li>Module 2 - Assessing risks <br></li><li>Module 3 - Controlling risks <br></li><li>Module 4 - Understanding responsibilities <br></li><li>Module 5 - Understanding hazards <br></li><li>Module 6 - Investigating Incidents <br></li><li>Module 7 - Measuring Performance<br></li></ul><p><strong>Study Method</strong></p><p>Rather than being tied down to a classroom schedule, candidates can access our e-learning courses 24 hours a day, seven days a week. This added flexibility means you can study at a time and place that suits you. </p><p>Each user has easy log in access to their own secure learning account. The online learning system is extremely user-friendly, and can be accessed on computer, tablet and/or smartphone. No matter what device users log in with, they are able to resume their learning at any time, from any device.</p><p>Each individual module includes:</p><ul><li>Learning objectives, with an overview of the module and what is required <br></li><li>All required course learning content <br></li><li>Short films and video clips <br></li><li>Interactive revision exercises and learning activities <br></li><li>Links to further reading and additional reference materials<br></li></ul><p><strong>Support</strong></p><p>Our team of expert mentors will be available to offer full learning support throughout the duration of the course. Tutors can be contacted by email, telephone, Skype, social media or via the online learning platform.</p><p><strong>Exams and Certification </strong></p><p>To achieve the full certificate, candidates will need to complete a multiple choice examination and a practical assessment. All assessments can be completed online, meaning you never have to attend our premises to gain the qualification. </p><p>Candidates should aim to complete their final assessments within three months of purchase. After the course has been purchased, IOSH registration is restricted to six months, providing candidates with enough time for one resit. 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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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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]</li><li> Conduct periodic compliance self-audit to identify potential compliance issues </li><li> Perform activities related to pharmacovigilance (PhV) and materiovigilance according to Corporate and if applicable, by local regulations. </li><li> Ensure that all functions perform in accordance with the Standard Operating Procedures to meet the Good Distribution Guidelines </li><li> 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)</li><li> Take corrective actions plans based on regulatory and pharmacovigilance audit findings </li> </ul> <p>5. <b> Regulatory Influence </b> </p> <p><u> External </u> </p> <ul><li> Regulatory Customer Relations Establish relationship with key regulatory officials to influence regulators to foster positive regulatory environment for business and research. </li><li> 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. </li><li> Influence Strategy Supports the development and implementation of the established external regulatory influence strategy. </li><li> Trade Association- Work with Trade Associations in Malaysia on different Regulatory issues and share company position on different topics. </li> </ul> <p><u> Internal </u> </p> <p> a) Affiliate Organization </p> <ul><li> Learn and understand the local affiliate organization and functions. </li><li> Build functional partnership and credibility to maximize regulatory value in support of business decisions. 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Fresenius medical care
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IOSH Working Safely with Exam & Certificate Phoenix Health & SafetyAED 396
AED 489Duração: 8 Hours -
IOSH Managing Safely Version 5 with Exam & Certificate Phoenix Health & SafetyAED 909
AED 1,120Duração: 24 Hours
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https://my.jooble.org/external/4738821711906095478?cpc=d0FU&utm_source=affiliate&utm_medium=laimoon_organic_my&extra_ars_request_id=2d6cb513cb18dd113d23bf48c55f905f