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 begins by giving you the legal background behind those terms.<br /> <br /> Next, it covers the patterns that are evident in workplaces with permissive attitudes towards discrimination and harassment.<br /> <br /> Specific strategies that employees and employers can implement are discussed next.<br /> <br /> Finally, the last module outlines what to do, if you witness or are a victim of workplace harassment or discriminatory hiring or promotion practices.<br /> You will Learn:<br /> <ul class="learn-mod"><br /> <li>What a 'protected characteristic' is;</li><br /> <li>Details about the legislation that covers harassment and discrimination at work;</li><br /> <li>Tips on how to recognise a toxic working atmosphere;</li><br /> <li>How reviewing the hiring and promotion practices of a company can indicate the level of discrimination that you can anticipate encountering;</li><br /> <li>What a zero-tolerance policy is, and why your company should have one;</li><br /> <li>Information on what constitutes a fair complaints process.</li><br /> </ul><br /> Benefits of Taking this Course:<br /> <ul class="learn-benefit"><br /> <li>Learning more about workplace discrimination and harassment, including the definitions of each term;</li><br /> <li>Understanding how corporate culture and retention rates reflect the likelihood of encountering discrimination or harassment at work;</li><br /> <li>Learning what information should be in employee training programmes, if a workplace is serious about preventing harassment and discrimination;</li><br /> <li>Learning how to develop a complaints process that is fair for everyone involved;</li><br /> <li>Understanding what steps you should take, if you witness or are the victim of harassment or discrimination at work.</li><br /> </ul></p>', 'outline' => null, 'who_should_take_this_course' => null, 'career_path' => null, 'eligibility' => 'There are no formal requirements to take up the course, anyone who is interested in the topic and/or would like to gain more knowledge and stand out to make up your career that you are passionate of.', 'school' => 'Online Courses Learning', 'keywords' => 'Preventing Workplace Discrimination ', 'location' => 'Online', 'duration' => 'Upto 3 Hours', 'timing' => 'Flexible', 'cost' => null, 'discount' => '50% Off for Laimoon Users!', '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' => '43412517', '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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Fresenius medical care
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