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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It not only involves the presentation and preparation of delicious foods but also concerns <strong>Certificate in Food Hygiene and Safety</strong>. It is a great responsibility for restaurant owners to ensure a healthy and hygienic environment with nutritious food.<br> <br> The <strong>Certificate in Food Hygiene and Safety</strong> course teaches you about food hygiene and HACCP. Without clean premises, your restaurant can be shut down by the health service.<br> <br> The physical, chemical, and biological hazards faced in the food industry will be thoroughly explained in the <strong>Certificate in Food Hygiene and Safety</strong> course. Finally, you will learn how to maintain a hygienic environment for your valuable customers.<br> <br> <strong>What you will learn in Food Safety & Hygiene Management for Supervisor</strong> <strong>course :</strong> <ul> <li>Understand the roles and responsibilities of a food supervisor</li> <li>Enrich your knowledge of law and legislation regarding food safety</li> <li>Familiarise with the Food Safety Management System and HACCP</li> <li>Learn the skills to detect and prevent food contamination</li> <li>Know the strategies of hazard control</li> <li>Gain the skills for risk control and pest management</li> </ul> <strong>Course Highlights</strong> <ul> <li>The price is for the whole Certificate in Food Hygiene and Safety course including the final exam - no hidden fees</li> <li>Accredited Certificate upon successful completion at an additional cost</li> <li>Efficient exam system with instant results</li> <li>Track progress within own personal learning portal</li> <li>24/7 customer support via live chat</li> </ul> <br> <strong>COURSE CURRICULUM</strong><br> <br> <strong>Food Safety & Hygiene Management for Supervisor</strong> <ul> <li>Introduction to Food Safety</li> <li>Roles and Responsibilities of a Food Supervisor and Policies</li> <li>Laws and Legislation</li> <li>Introduction to Food Safety Management Systems (FSMS) and HACCP</li> <li>Implementation and Tools of FSMS</li> <li>Food Poisoning Causes</li> <li>Detecting and Preventing Contamination</li> <li>Hazard Control</li> <li>Food Poisoning in Detail and Illnesses</li> <li>Food Toxins and their Prevention</li> <li>Food Handling Risks and Practices</li> <li>Temperature Control</li> <li>Recording Temperatures</li> <li>Spoilt Food and its Prevention</li> <li>Design Aspects of Food Premises</li> <li>Waste Disposal, Cleaning and Disinfection</li> <li>Pest Management</li> <li>Training and Supervising Staff Effectively</li> </ul> <br> <strong>Certificate in Food Hygiene and Safety </strong>course has been given CPD and IAO accreditation and is one of the best-selling courses available to students valuable Certificate in Food Hygiene and Safety course is suitable for anyone interested in working in this sector or who simply wants to learn more about the topic.<br> <br> If you're an individual looking to excel within this field then <strong>Certificate in Food Hygiene and Safety</strong> is for you. It provides all the basic knowledge about food hygiene and safety is for you.<br> <br> <strong>Certificate in Food Hygiene and Safety</strong><strong> </strong>is a comprehensive course. We've broken this food hygiene and safety course down into several manageable modules which we believe will assist you to easily grasp each concept - from the fundamental to the most advanced aspects of the Certificate in Food Hygiene and Safety course. It really is a sure pathway to success.<br> <br> All our courses offer 3 months access and are designed to be studied at your own pace so you can take as much or as little time as you need to complete and gain the full CPD accredited qualification. And, there are no hidden fees or exam charges.<br> <br> We pride ourselves on having friendly and experienced instructors who provide full weekday support and are ready to help with any of your queries. So, if you need help, just drop them an email and await a speedy response.<br> <br> Furthermore, you can check the validity of your qualification and verify your certification on our website at any time.<br> <br> So, why not improve your chances of gaining professional skills and better earning potential.<br> <br> <br> <strong>Assessment and Certification</strong><br> <br> At the end of the <strong>Certificate in Food Hygiene and Safety</strong> course, you will be required to sit an online multiple-choice test. Your test will be assessed automatically and immediately so that you will instantly know whether you have been successful. After you have successfully passed the final exam, you will be able to order an Accredited Certificate of Achievement.<br> <br> <strong>Career Path</strong><br> <br> Not only does our CPD and CiQ accredited course look good on your CV, setting you apart from the competition, but it can also be used as a stepping stone to greater things. 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It not only involves the presentation and preparation of delicious foods but also concerns <strong>Certificate in Food Hygiene and Safety</strong>. It is a great responsibility for restaurant owners to ensure a healthy and hygienic environment with nutritious food.<br> <br> The <strong>Certificate in Food Hygiene and Safety</strong> course teaches you about food hygiene and HACCP. Without clean premises, your restaurant can be shut down by the health service.<br> <br> The physical, chemical, and biological hazards faced in the food industry will be thoroughly explained in the <strong>Certificate in Food Hygiene and Safety</strong> course. Finally, you will learn how to maintain a hygienic environment for your valuable customers.<br> <br> <strong>What you will learn in Food Safety & Hygiene Management for Supervisor</strong> <strong>course :</strong> <ul> <li>Understand the roles and responsibilities of a food supervisor</li> <li>Enrich your knowledge of law and legislation regarding food safety</li> <li>Familiarise with the Food Safety Management System and HACCP</li> <li>Learn the skills to detect and prevent food contamination</li> <li>Know the strategies of hazard control</li> <li>Gain the skills for risk control and pest management</li> </ul> <strong>Course Highlights</strong> <ul> <li>The price is for the whole Certificate in Food Hygiene and Safety course including the final exam - no hidden fees</li> <li>Accredited Certificate upon successful completion at an additional cost</li> <li>Efficient exam system with instant results</li> <li>Track progress within own personal learning portal</li> <li>24/7 customer support via live chat</li> </ul> <br> <strong>COURSE CURRICULUM</strong><br> <br> <strong>Food Safety & Hygiene Management for Supervisor</strong> <ul> <li>Introduction to Food Safety</li> <li>Roles and Responsibilities of a Food Supervisor and Policies</li> <li>Laws and Legislation</li> <li>Introduction to Food Safety Management Systems (FSMS) and HACCP</li> <li>Implementation and Tools of FSMS</li> <li>Food Poisoning Causes</li> <li>Detecting and Preventing Contamination</li> <li>Hazard Control</li> <li>Food Poisoning in Detail and Illnesses</li> <li>Food Toxins and their Prevention</li> <li>Food Handling Risks and Practices</li> <li>Temperature Control</li> <li>Recording Temperatures</li> <li>Spoilt Food and its Prevention</li> <li>Design Aspects of Food Premises</li> <li>Waste Disposal, Cleaning and Disinfection</li> <li>Pest Management</li> <li>Training and Supervising Staff Effectively</li> </ul> <br> <strong>Certificate in Food Hygiene and Safety </strong>course has been given CPD and IAO accreditation and is one of the best-selling courses available to students valuable Certificate in Food Hygiene and Safety course is suitable for anyone interested in working in this sector or who simply wants to learn more about the topic.<br> <br> If you're an individual looking to excel within this field then <strong>Certificate in Food Hygiene and Safety</strong> is for you. It provides all the basic knowledge about food hygiene and safety is for you.<br> <br> <strong>Certificate in Food Hygiene and Safety</strong><strong> </strong>is a comprehensive course. We've broken this food hygiene and safety course down into several manageable modules which we believe will assist you to easily grasp each concept - from the fundamental to the most advanced aspects of the Certificate in Food Hygiene and Safety course. It really is a sure pathway to success.<br> <br> All our courses offer 3 months access and are designed to be studied at your own pace so you can take as much or as little time as you need to complete and gain the full CPD accredited qualification. And, there are no hidden fees or exam charges.<br> <br> We pride ourselves on having friendly and experienced instructors who provide full weekday support and are ready to help with any of your queries. So, if you need help, just drop them an email and await a speedy response.<br> <br> Furthermore, you can check the validity of your qualification and verify your certification on our website at any time.<br> <br> So, why not improve your chances of gaining professional skills and better earning potential.<br> <br> <br> <strong>Assessment and Certification</strong><br> <br> At the end of the <strong>Certificate in Food Hygiene and Safety</strong> course, you will be required to sit an online multiple-choice test. Your test will be assessed automatically and immediately so that you will instantly know whether you have been successful. After you have successfully passed the final exam, you will be able to order an Accredited Certificate of Achievement.<br> <br> <strong>Career Path</strong><br> <br> Not only does our CPD and CiQ accredited course look good on your CV, setting you apart from the competition, but it can also be used as a stepping stone to greater things. 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It is suitable for entry-level positions where a foundational understanding of food safety is essential.<br /> <br /> <strong>Why Choose Us?</strong> <ul> <li>Affordable, engaging & high-quality e-learning study materials.</li> <li>Tutorial videos/materials from the industry-leading experts.</li> <li>Study in a user-friendly, advanced online learning platform.</li> <li>Efficient exam systems for the assessment and instant result.</li> <li>The UK & internationally recognized accredited qualification.</li> <li>Access to course content on a mobile, tablet, or desktop from anywhere, anytime.</li> <li>The benefit of career advancement opportunities.</li> <li>24/7 student support via email.</li> </ul> <br /> <strong>Career Path</strong><br /> <br /> Graduates of this course may pursue roles such as Food Handler, Kitchen Assistant, or Catering Staff in various food establishments.<br /> <br /> <strong>Course Curriculum</strong><br /> <br /> <strong><em>Food Hygiene Level 1 Diploma</em></strong> <ul> <li>Module 01: Introduction To Food Safety</li> <li>Module 02: Food Poisoning And Other Illnesses</li> <li>Module 03: Contamination</li> <li>Module 04: Waste Disposal, Cleaning And Disinfection</li> <li>Module 05: Personal Hygiene</li> </ul> ', 'outline' => null, 'who_should_take_this_course' => null, 'career_path' => 'Food Handler,Kitchen Assistant,Catering Staff,Food Safety Trainee', 'eligibility' => 'This Food Hygiene Level 1 Diploma course is open to individuals entering or currently working in the food industry. No specific prerequisites are needed, making it accessible to those seeking basic food hygiene training.', 'school' => 'Alpha Academy', 'keywords' => 'Food Safety,Food Hygiene,Contamination Prevention,Personal Hygiene,Waste Disposal', 'location' => 'Online', 'duration' => 'Upto 1 Hour', 'timing' => 'Flexible', 'cost' => null, 'discount' => null, 'eligibility_criteria' => null, 'job_matching_keywords' => null, 'boosted' => '0', 'lang_code' => 'en', 'status' => 'active', 'auto_translated' => '0', 'objectives' => null, 'photo' => null, 'photo_cta' => null, 'video' => null ), 'Profile' => array() ) ) $job = array( 'Job' => array( 'id' => '43412666', 'contact_id' => '3773199', 'recruiter_id' => '74726', 'job_function_id' => null, 'title' => 'Manager, Regulatory Affairs', 'vacancies' => null, 'job_type_id' => null, 'description' => null, 'pay_status' => 'Free', 'external_job_description' => '<p><p><b> Key Responsibilities / Accountabilities: </b> </p> <p><b> Pharmacovigilance </b> </p> <ul><li> Collection of local AEs / ADRs </li><li> Contact point for local regulatory authorities </li><li> Forwarding of case reports and other 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. Regulatory Compliance </b> </p> <p><u> a) Compliance Maintenance </u> </p> <ul><li> 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]</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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https://my.jooble.org/external/4738821711906095478?cpc=d0FU&utm_source=affiliate&utm_medium=laimoon_organic_my&extra_ars_request_id=a20f2935ad683f0f1da440ebd9f4b530