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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You will learn about the most frequent hazards that workers face on a daily basis and legal aspects, benefits of the positive and healthy environments, different steps of risk management and its practical process.<br /> <br /> This Workplace Health and Safety course will also equip you with a solid foundation in health and safety law in the UK in both theory and practice, and the safety rules to lessen risks.<br /> <br /> <strong>Key features of the Workplace Health and Safety course:</strong> <ul> <li>Lifetime access to the course</li> <li>No hidden fees, only pay the price of the course which includes exam fees.</li> <li>Recognised qualification upon successful completion of the course</li> <li>Study from anywhere, anytime, whenever it is convenient for you.</li> <li>Affordable and engaging e-learning study materials</li> <li>Study at your own pace from tablet, PC or smartphone</li> <li>Online tutor support when you are in need.</li> </ul> <br /> <strong>Who is this Workplace Health and Safety course for?</strong><br /> <br /> There is no experience or previous qualifications required for enrolment on this course. It is available to all students, of all academic backgrounds.<br /> <br /> <strong>Workplace Health and Safety Course Curriculum</strong><br /> <br /> <strong>Health and Safety at Workplace</strong> <ul> <li>Introduction</li> <li>Health and Safety Related Accidents and ill-health</li> <li>Legal Responsibilities and Requirements</li> <li>Managing health and safety in the Workplace</li> <li>Health and Safety in The workplace</li> <li>Workplace Hazards, Slips and Trips</li> <li>General fire safety</li> <li>Work at height0</li> <li>Building work</li> <li>Machinery safety</li> <li>Plant and equipment maintenance</li> <li>Workplace transport</li> <li>Lifting and handling</li> <li>Noise, Vibration</li> </ul> <br /> <strong>Importance of Workplace Safety</strong> <ul> <li>Why Workplace Health & Safety are Important</li> <li>It Takes Team Effort!</li> <li>Some Rules are Compulsory</li> <li>Rewarding Compliance</li> <li>You Need a Backup Plan Always</li> <li>Dealing with Issues and Concerns</li> <li>How to Deal with Noncompliance</li> <li>Remember What the Workplace is for</li> <li>Make Your Workplace a Good Place</li> <li>Conflict Resolution</li> <li>Are Dress Codes Appropriate?</li> <li>Minimizing Distractions</li> <li>People Who Work After Hours</li> <li>Your Fire Safety Plan</li> </ul> <br /> <strong>Health and Safety at Workplace (for the USA)</strong> <ul> <li>Getting Started</li> <li>An Overview</li> <li>Types of Hazards</li> <li>Managers Role</li> <li>Training</li> <li>Stress Management</li> <li>Workplace Violence</li> <li>Identifying Your Company Hazards</li> <li>Drug & Alcohol Abuse</li> <li>Writing the Safety Plan</li> <li>Implement the Plan</li> <li>Wrapping Up</li> </ul> <br /> <strong>Assessment and Certification</strong><br /> <br /> The course is assessed online with a multiple-choice test, which is marked automatically. 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Through video demonstrations and expertly designed course modules, you’ll be trained on the safety measures, such as how to assess risks in the workplace, learning how to use a fire extinguisher correctly and how to safely evacuate your co-workers.</strong><br /> <br /> According to The Regulatory Reform (Fire Safety) Order 2005, there must be a fire warden for each floor for every workplace, so that in the case of an emergency there is someone who is trained to carry out the correct safety measures and evacuation procedures. A fire warden is expected to carry out at least two fire drills per year.<br /> <br /> Once you’ve completed the course, you’ll have learned all about the responsibilities duties of a fire warden and how to comply with fire safety legislation in a workplace setting. This introductory course is divided into easy to follow sections that can be accessed from any device with an internet connection. <ul> <li>Accredited by CPD</li> <li>Complies with Fire Safety Order 2005</li> <li>Instant e-certificate and hard copy dispatch by next working day</li> <li>Developed by qualified professionals</li> <li>Fully online, interactive course with audio voiceover</li> <li>Self-paced learning and laptop, tablet, smartphone-friendly</li> <li>24/7 Learning Assistance</li> <li>Discounts on bulk purchases</li> </ul> <strong>Who should take the course</strong><br /> <br /> This comprehensive course is ideal for any individual in a company that wishes to learn the duties of a Fire Warden. This can include; <ul> <li>Office workers</li> <li>Factory workers</li> <li>Property owners</li> <li>Shopworkers</li> <li>Leisure facility workers</li> <li>Teachers </li> </ul> <strong>Learning Outcomes</strong><br /> <br /> By the end of the course learners will be able to demonstrate that they can: <ul> <li>Understand all appropriate UK Fire and Safety regulations.</li> <li>Exhibit knowledge of how a fire can start and also be prevented.</li> <li>Perform a risk assessment for a building.</li> <li>Learn the fire evacuation plan of any property and memorise every detail.</li> <li>Coordinate with the workforce and rescue services in ensuring colleagues' safety.</li> <li>Be trusted to circulate and enforce a PEEP (Personal Emergency Evacuation Plan – for people with vulnerabilities).</li> </ul> <strong>Assessment</strong><br /> <br /> At the end of the course, there will be an online assessment, which you will need to pass to complete the course. 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Through video demonstrations and expertly designed course modules, you’ll be trained on the safety measures, such as how to assess risks in the workplace, learning how to use a fire extinguisher correctly and how to safely evacuate your co-workers.</strong><br /> <br /> According to The Regulatory Reform (Fire Safety) Order 2005, there must be a fire warden for each floor for every workplace, so that in the case of an emergency there is someone who is trained to carry out the correct safety measures and evacuation procedures. A fire warden is expected to carry out at least two fire drills per year.<br /> <br /> Once you’ve completed the course, you’ll have learned all about the responsibilities duties of a fire warden and how to comply with fire safety legislation in a workplace setting. This introductory course is divided into easy to follow sections that can be accessed from any device with an internet connection. <ul> <li>Accredited by CPD</li> <li>Complies with Fire Safety Order 2005</li> <li>Instant e-certificate and hard copy dispatch by next working day</li> <li>Developed by qualified professionals</li> <li>Fully online, interactive course with audio voiceover</li> <li>Self-paced learning and laptop, tablet, smartphone-friendly</li> <li>24/7 Learning Assistance</li> <li>Discounts on bulk purchases</li> </ul> <strong>Who should take the course</strong><br /> <br /> This comprehensive course is ideal for any individual in a company that wishes to learn the duties of a Fire Warden. This can include; <ul> <li>Office workers</li> <li>Factory workers</li> <li>Property owners</li> <li>Shopworkers</li> <li>Leisure facility workers</li> <li>Teachers </li> </ul> <strong>Learning Outcomes</strong><br /> <br /> By the end of the course learners will be able to demonstrate that they can: <ul> <li>Understand all appropriate UK Fire and Safety regulations.</li> <li>Exhibit knowledge of how a fire can start and also be prevented.</li> <li>Perform a risk assessment for a building.</li> <li>Learn the fire evacuation plan of any property and memorise every detail.</li> <li>Coordinate with the workforce and rescue services in ensuring colleagues' safety.</li> <li>Be trusted to circulate and enforce a PEEP (Personal Emergency Evacuation Plan – for people with vulnerabilities).</li> </ul> <strong>Assessment</strong><br /> <br /> At the end of the course, there will be an online assessment, which you will need to pass to complete the course. 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