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Quality and Regulatory Specialist at Roche Diagnostics – Pharmaceutical Sciences Apply Online

The Position Quality and Regulatory Specialist

Reporting to the Q&R Sub-chapter lead – APAC Business Excellence Chapter

Roche Diagnostics Asia Pacific

Role Purpose:

As a Quality and Regulatory Affairs specialist, your primary focus is to support Roche Dia, with a secondary focus on Diabetes Care topics. You will be responsible for supporting product launch projects, affiliates with tasks related to the Regulatory Information Management System (RIMS) implementation and capacity building for the APAC Q&R community and coordinate Q&R regional led meetings. You will also be responsible for managing and updating the Q&R gSite, as supporting other strategic regulatory projects as required by the business, as well as providing support for the regional and affiliate integration of DIA and DC Q&R function.

In this role, you will (be responsible for):

Product launch projects

(a) Manage and coordinate launch planning and submission in APAC markets, providing affiliates with regulatory support and guidance.

Regulatory Information Management System (RIMS)

(a) Be the RIMS Business Administrator, working closely with affiliates and stakeholders to achieve submission excellence.

(b) Help affiliates clean up their data via automatic uploads.

(c) Develop submission folders to drive submission

management (reduce double archiving of registration dossiers).

(d) Governance of Data in RIMS.

(e) Provide overviews of registration activities in APAC and establish dashboard for countries for the management teams.

(f) Provide registration status of projects to the region.

(g) Engage affiliates in usage of RIMS and administrative support of trainings.

Capacity building and meeting coordination

(a) Conduct assessment to identify gaps and training requirements.

(b) Collaborate seamlessly with internal and external stakeholders to plan & coordinate administrative, logistical aspects of training.

(c) Initiative to ensure efficient execution; taking into account Roche organizational policies and requirements.

(d) Evaluate effectiveness of training initiative.

(e) Coordinate all aspects of meetings/conferences, and events, ensuring smooth and efficient execution.

(f) Assist in the planning and scheduling of meetings, including booking venues, arranging catering, and coordinating logistics.

(g) Prepare and distribute meeting agendas, materials, and presentations in a timely manner.

(h) Ensure that all necessary equipment and technology are set up and functioning properly for meetings.

(i) Coordinate and confirm attendance of participants, managing RSVPs and sending out meeting reminders.

(j) Take accurate meeting minutes and distribute them to attendees in a timely manner.

(k) Maintain an organized system for filing and archiving meeting-related documents and materials.

(l) Assist in the preparation and distribution of post-meeting reports and action items.

(m) Act as a point of contact for meeting-related inquiries and provide support to meeting participants as needed.

(n) Collaborate with internal teams and external vendors to ensure successful event coordination.

(o) Stay updated with relevant tools and technologies for efficient meeting management.

(p) Continuously identify opportunities for process improvement and implement best practices.

Managing Q&R gSite and supporting other strategic regulatory projects

(a) Update APAC Q&R gSite through managing and maintaining the content- ensuring accuracy, functionality and a positive user experience.

(b) Collaborate with cross-functional teams to gather and update gSite content, including text, images, videos and downloadable resources.

(c) Support regional operations and strategy community of practice and respective squads.

Supporting Fusion Project Integration

(a) Prepare registration and notification listing.

(b) Integrate processes and database for registration and quality management system.

(c) Prepare documentation for licenses update.

Who you are:

  • Excellent attention to detail and ability to analyze complex information.
  • Be process driven and logical thinking.
  • Willingness to learn and ability to work independently and manage multiple projects simultaneously.
  • Strong communication and interpersonal skills (such as negotiation) to effectively collaborate with cross-functional teams.
  • Be a team player with strong sense of responsibility.

Qualification and Experience

  • Possess a degree in Pharmaceutical or Science related field (preferably medical laboratory related).
  • 2 to 5 years of experience in Regulatory Affairs (experience in IVD/Medical Device will be an added advantage).
  • Project management skills (proficient in using project management tools such as Trello, Lucid etc.) and ability to prioritize tasks to meet deadlines.
  • Proficient in using regulatory databases and software.

Link to original notification to apply: Apply Here

Keywords: Quality and Regulatory Specialist, Regulatory Affairs, Roche Diagnostics, APAC, Regulatory Information Management System, RIMS, Pharmaceutical, Science, Project Management. Quality and Regulatory Specialist at Roche Diagnostics – Pharmaceutical Sciences Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.

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