Associate Director, Business Process and Information Management

The Associate Director, Regional Business Process and Information Management (BPIM) will be the lead for the regional activities associated with the implementation and support of the GRAC team's Information Management (IM) Strategy projects and systems. The person in this role will play a critical role to connect the activities of the BPIM group in Headquarters to the users in the regional hubs and out to the Country RA groups in the specific region in which they work from the three major GRACS regions (Latin America: Europe, Middle East and Africa; Asia Pacific). They will ensure that regional needs are understood and translated into the requirements for the system and are communicated within the project team, both to the global team members but also back to the region and country RA. They will also ensure that tasks within the global project that require regional input are successfully completed. The person in this role will represent their region in the global project activities and lead the regional team in managing and completing the regional tasks. When a particular change only affects the region this person works in, they will be responsible for leading the overall team and meeting the project objectives and deliverables. The person in this role may also be involved in regional projects that support the local business and regulatory strategy where their skill set and experience in leading and working in teams looking at change management and business process development can be used.

The person in this role will generally focus on one or two projects at any one time across the GRACS Information Strategy portfolio (current priorities include content management for regulatory submissions; submission planning tools and processes; regulatory information management systems for product information and registration management) but may need to provide support or information across other projects on an as needed basis. On occasions, the person in this role may take on roles and tasks as part of the global implementation project team for a specific project. The ability to prioritise their workload and work to deliver the objectives of their projects will be a key marker of success in this role.

Primary Activities include but are not limited to:
* Lead and manage the regional input to global IM Strategy projects, in agreement with the global project leads. As needed, work with colleagues from RAI, Regional CMC and other GRACS subfunctions to establish subteams to deliver the regional objectives and deliverables
* Lead and manage regional IM Strategy projects. As needed, work with colleagues from RAI, Regional CMC and other GRACS subfunctions to establish teams to deliver the objectives and deliverables
* Lead and manage the development of business processes and change management initiatives associated with IM Strategy projects. They may lead or be involved in regional business process projects.
* Provide and manage regional input to the GRACS IM Strategy, ensuring that the IM Strategy evolves with the regional needs and landscape. Understanding changes in the external environment that affect the IM strategy.
* Enable efficient processes and clear communication for IM Strategy projects by collaborating with Reg Ops HQ staff in BPIM and regional and country RA staff in the main GRACS Regions
* Provide strong, cross-functional team leadership in a virtual environment for IM Strategy projects within the region and manage senior leader interactions and collaborations (team size typically 5-10 people)
* Report on progress on delivery of regional objectives to Regional Management, Project team Leads and other Senior Managers as required.
* Collaborate with other Regional BPIM staff to align activities, share best practices and ensure the efficient completion of future projects
* As agreed with regional leaders and global project leaders, perform global roles within IM Strategy projects
* As needed, organise and oversee the work of contract and sourced resources who are allocated by the International Reg Ops group and Regional Reg Ops Lead to support IM Strategy project work in the region

Education Minimum Requirement:
* Bachelor's degree in a science or information technology discipline required

Required Experience and Skills -
* Min of 5-8 years' experience in Regulatory Affairs and/or Regulatory Operations, with at least 3 years' experience in implementing and/or supporting regulatory information systems (e.g. document management systems such as Documentum or Veeva, submission publishing tools such as eCTDXpress or InSight, regulatory information management tools such as InSight or ArisGlobal, etc.).
* Good understanding of System Development Life Cycle methodology and the requirements for the validation of information management systems.
* Demonstrated understanding of drug development and execution of regulatory program strategies within the countries making up the region and how this impacts regulatory IM strategies
* Proven experience as a leader on cross functional teams and able to influence and motivate team members and Senior Management leading to high quality and on-time delivery of project objectives.
* Demonstrated situational leadership and creative problem solving within organizations and teams
* Ability to prioritise their own work across several ongoing projects
* Ability to lead by influence and work effectively in matrix organizational structures
* Ability to understand details, but keep overall "big picture" view of projects

Desired Experience and Skills -
* Expertise in project management methodologies (e.g. PMBok, Lean Six Sigma, Change Management, etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
* Advanced degree preferred (engineering or scientific discipline, MBA)

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the pharmaceutical and medical devices industry, please contact Jennifer Ha at j.ha(@)realstaffing.com or contact +65 6871 4700.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Gloabl Recruiters 2017

Monthly Salary: SGD 13000

Application Email: JIHA.65904.3273@sthreesg.aplitrak.com