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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This comprehensive Lone Worker Safety Practice training program is your ultimate guide to a successful career in this field. Whether you're a seasoned professional seeking to refine your expertise or a newcomer eager to jumpstart your career, Lone Worker Safety Practice Online Training has everything you need to excel.<br /> <br /> <strong>With this Lone Worker Safety Practice course, you will get a CPD-accredited PDF certificate and our exclusive student ID card absolutely free.</strong><br /> <br /> In this Lone Worker Safety Practice, you'll master the core skills of this sector, transforming from novice to confident expert. You will learn from industry experts, ensuring this immersive programme will ignite your creativity and fuel your problem-solving prowess with interactive exercises. And the reward? A coveted CPD-accredited certificate to showcase your newfound expertise. 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This comprehensive Lone Worker Safety Practice training program is your ultimate guide to a successful career in this field. Whether you're a seasoned professional seeking to refine your expertise or a newcomer eager to jumpstart your career, Lone Worker Safety Practice Online Training has everything you need to excel.<br /> <br /> <strong>With this Lone Worker Safety Practice course, you will get a CPD-accredited PDF certificate and our exclusive student ID card absolutely free.</strong><br /> <br /> In this Lone Worker Safety Practice, you'll master the core skills of this sector, transforming from novice to confident expert. You will learn from industry experts, ensuring this immersive programme will ignite your creativity and fuel your problem-solving prowess with interactive exercises. And the reward? A coveted CPD-accredited certificate to showcase your newfound expertise. 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It is important that both employees and their employers understand the risks associated with working from height and that they know how to use equipment in a safe, appropriate manner. An individual can sustain an injury falling just a couple of metres. They can also suffer a back injury if they fail to take precautions when moving and positioning equipment.<br /> <br /> Stepladders are used frequently in the workplace, so it is essential that employees know when and how to use them. This course will provide you with a comprehensive overview of the risks associated with stepladders, how to put in place effective precautionary measures and how to ensure that equipment is fit for purpose. 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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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