Roche Hiring for Quality and Regulatory Specialist - Apply online

Roche Hiring for Quality and Regulatory Specialist – Apply online

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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

(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.

Supporting Fusion Project Integration

(a) Prepare registration and notification listing

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

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.

Location:

Preferred location will be Singapore, however other locations within Asia Pacific may also be considered. At the Company’s discretion, an exception to the location requirement could be made under extraordinary circumstances.

APAC:

This is a diverse region culturally and with respect to business maturity. APAC Spirit is an embodiment of the organization we in the APAC region aspire to be. As a member in this region, you will strive to deeply understand, live and encourage those around you to embrace the APAC Spirit principles.

As this position is a regional role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.