Senior Specialist, System Process & Regulatory Innovation (SPRI) - APAC
- Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
- Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
The Senior Specialist, System Process & Regulatory Innovation (SPRI) supports regional activities associated with the implementation and support of Global Regulatory Affairs, Clinical and Safety (GRACS) Digital Strategy projects and systems.
Demonstrating a good degree of competence in regulatory affairs and supporting business processes, this role provides support across a portfolio of systems and their related capabilities including but not limited to the following: content management for regulatory submissions; submission planning & execution; health registration & regulatory information management systems.
This role partners with Regulatory Innovation & Information Management (RIIM), Business System Owners (BSOs) and key regional stakeholders to ensure the successful regional implementation of GRACS Regulatory systems and to support continuous enhancements of capabilities and processes.
The Regional SPRI Senior Specialist will support all countries in the region and will represent regional needs for system and process changes in global project activities. They are responsible for understanding the underlying business processes that the systems support and where necessary, work with Business Process Owners (BPOs) to adapt those procedures to align with regional needs and/or country-specific requirements and will be required to demonstrate a knowledge of process excellence and regulatory technology innovation. Digital skills, including the use of PowerApps and ChatGPT would be beneficial.
WHAT YOU WILL DO
In this role they will be the primary contact for the regional users with regards to questions on system usage, existing process, and subsequent process improvement initiatives or support an Associate Director or other team member as a secondary line of support; and may provide additional user training as required.
They will be responsible for evaluation of regional data and creating and/or implementing action plans for the region to address data quality and compliance issues. They will also ensure that tasks within the global projects that require regional input are completed in a timely manner.
The Regional SPRI Senior Specialist may also be involved in regional projects that support the local business and regulatory strategy where their skillset and experience in participating in teams, change management and business process development can be used. This is particularly true on projects with a linkage between technology enablement of business processes including automation opportunities. Project Management should be clearly understood and the ability to create and contribute to project plans is a requirement. Critical thinking and problem solving are also core competencies.
Responsibilities include, but are not limited to:
- Work with colleagues from Regulatory Affairs International (RAI), International Chemistry and Manufacturing Control (iCMC), GRACS O.P.S, Pharmacovigilance (PV) and other GRACS functions to deliver on regional objectives.
- Understand the regional needs and changes in the external environment, interpret and translate these into actionable plans that are integrated into the GRACS Digital Strategy and departmental priorities as applicable. Participate in the development of communications and change management initiatives associated with GRACS Digital Strategy projects.
- For identified GRACS RIIM tools, provide direct support to system users within the region to build good data management practices e.g., timely and accurate data entry, explore and deploy automations for highly standardized and repetitive tasks, support additional system user trainings and system-process improvement collaborations.
- Participate in and/or organize the Regional Communication forums to enable dissemination of knowledge on business processes and system changes that impact GRACS RIIM Systems.
- Represent the needs of the Region in different Change Control Boards, Communities of Practice, etc., to ensure that changes are appropriate for the region.
- Assist in developing and facilitating global regulatory training when new business processes are rolled out or new functionalities are implemented. Provide additional refresher training, as needed.
- Provide operational metrics and dashboards on a periodic basis, report on the progress of delivery of regional objectives and strategic initiatives (projects) to Regional Management, Project Team Leads and other Senior Managers, as necessary.
- Collaborate with other Regional SPRI staff to align activities, share best practices, and ensure the efficient completion of future projects and explore opportunities to implement automation-based solutions.
WHAT YOU MUST HAVE
To be successful in this role, you will have:
- Bachelor’s degree in a science, information technology or Pharmacy discipline required.
- Advanced degree preferred (engineering or scientific discipline, MBA).
- Minimum of 2-4 years’ experience in Regulatory Affairs, or Regulatory Operations, and/or pharmaceutical manufacturing with at least 3 years’ experience in implementing and/or supporting regulatory information systems.
- Ability to lead and influence others with broad organizational awareness and knowledge of touch points and interdependencies.
- Ability to prioritize their own work across several ongoing projects.
- Demonstrate problem solving skills within organizations and teams with experience analyzing information and developing actions to improve data quality and process or system improvements.
- Experience in project management methodologies, change management, process re-engineering, analytics, and associated report generation (Cognos, PowerApps, ChatGPT), training material development and communication strategies beneficial.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
