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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Creating it for eLearning makes the course easier for people to commit to and complete; all they need to do is sign up online, pay for the course, and then work a manageable schedule.</p><p><strong>IOSH Working Safely Course Overview</strong></p><ul><li><strong>Introduction to working safely</strong> - This includes all primary safety issues in the workplace.<br></li><li><strong>Defining hazard and risks</strong> - This subject makes it clear that even established routines can present risks and serious consequences.<br></li><li><strong>Identification of common hazards</strong> - This includes all primary safety issues in the workplace.<br></li><li><strong>Protecting our environment </strong> - Sheds light on aspects of work operations that affect the environment and teaches how to reduce or completely eliminate negative effects.</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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It is an organisation that designs and accredits training courses to equip various industries with tried and true practices, and principles of workplace health and safety. One of the training courses it has come up with is the IOSH Working Safely Training.<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>Acknowledging how most people hoping to become IOSH-certified are so busy, the training course is designed for ease and flexibility to accommodate the unique schedule of learners. 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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. VAT charges (excluded in the price) will only apply for UK/EU based students. <br></p><p><strong>How it Works</strong></p><p>The course follows the latest IOSH Working Safely syllabus and consists of 4 modules, end of module quizzes, mock exams, free tutor support and an interactive, presentation style format. Your online exam and IOSH Certificate is included in the low price as well!</p><p><strong>The Exam Process </strong></p><p>The IOSH Working Safely exam process is entirely online! There are two, easy to complete, online exams for you to complete. You will have a short multiple choice exam and a spot the hazard exam as well. But don't worry! We supply everything you need to be successful including detailed guidance and all of the forms you need to complete. We've got you covered!</p><p><strong>The Support </strong></p><p>Full tutor support is given with your course. You don't need to feel like you are along during your studies. If you have any questions, the tutor is there to help. Most tutor support questions can be answered by a quick email exchange but if a phone call is in order, the tutor will arrange a convenient time for a call so it doesn't disturb your schedule. All of that at no additional cost to you. Don't fall for another cheap course that doesn't support you or worse yet, makes you pay for it! We are here to help you pass your course.</p><br>', 'outline' => '', 'who_should_take_this_course' => 'Everyone at work, especially those in production, manufacturing, construction and other potentially dangerous operations, should have an understanding of why they must “work safely.” This training course is the best way to create a solid foundation for the effective application of health and safety practices in their high-risk work environments.', 'career_path' => 'HSE Officer,Safety Officer,HSE Manager', 'eligibility' => 'No prior requirements are needed to take the program.', 'school' => 'Wise Global Training Ltd', 'keywords' => '', 'location' => 'Online', 'duration' => '6 Hours', 'timing' => '', 'cost' => null, 'discount' => '30% off through Laimoon!', 'eligibility_criteria' => '', 'job_matching_keywords' => 'IOSH', 'boosted' => '0', 'lang_code' => 'pt', 'status' => 'active', 'auto_translated' => '1', 'objectives' => null, 'photo' => null, 'photo_cta' => null, 'video' => null ), 'Profile' => array() ) ) $job = array( 'Job' => array( 'id' => '43412458', '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. 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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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Hiring company
Fresenius medical care
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Health and Safety at Work Global EdulinkAED 228Duração: Upto 80 Hours
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IOSH Working Safely Wise Global Training LtdAED 415
AED 556Duração: 6 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=a6e2a48c627fad721383ec5f25490a31