Regulatory Affairs - System Process & Innovation
About this role
Job Description
The
Regulatory Affairs - System Process & Innovation
will support regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems. With some understanding of 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 Innovation & Information Management (IIM), 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 will support all countries in the region for assigned capabilities 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/ country-specific requirements. 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, and will provide additional user training if required. They will be responsible for evaluation of regional data and creating / implementing action plans for the region to address data quality issues. They will also ensure that tasks within the global project that require regional input are successfully completed.
The
Regulatory Affairs - System Process & Innovation
I may also be involved in regional projects that support the local business and regulatory strategy where their skillset and experience in leading and working in teams, change management and business process development can be used, especially on projects with a linkage between technology enablement of business processes including automation opportunities.
They may also provide support or information across other projects and systems on an as needed basis and may take on roles and tasks as part of a global implementation project team for a specific project.
Primary Activities include but are not limited to:
Work with colleagues from Regulatory Affairs International (RAI), International Chemistry and Manufacturing Control (iCMC), Operations, Process & Systems (OPS) and other GRACS functions to deliver on regional objectives.
Understand the regional needs and changes in the external environment, ensuring that these are accounted for in the GRACS Digital Strategy and departmental priorities as applicable (e.g., RAI, CMC (Chemistry, Manufacturing and Control), Safety, etc.). Participate in the development of communications and change management initiatives associated with GRACS Digital Strategy projects.
Participate in / organize the Regional Communication forums to enable dissemination of knowledge on business processes and system changes that impact GRACS IIM Systems
Represent the needs of the Region in different Change Control Boards for their assigned systems to ensure that changes are appropriate for the region.
Provide direct support to system users in any region to correctly enter data into GRACS Systems, for low-frequency, high-complexity system interactions and/or explore automation-based solutions.
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 strong, cross-functional team leadership within the region and report on progress on delivery of regional objectives to Regional Management, Project Team Leads and other Senior Managers as required.
Collaborate with other Regional SPRI staff to align activities, share best practices, and ensure the efficient completion of future projects.
Education
Bachelor’s degree in a science, information technology or Pharmacy discipline required
Advanced degree preferred (engineering or scientific discipline, MBA).
Requirements
- Min 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
- Demonstrated experience using the Veeva platform is essential.
- Ability to lead and influence others with broad organizational awareness and knowledge of touch points/interdependencies
- Ability to prioritise their own work across several ongoing projects
- Demonstrate problem solving skills within organizations and teams with experience analysing information and developing actions to improve data quality and process or system improvements
- Experience in project management methodologies
- Experience with change management, developing training materials and communication strategies
Nice to have
- Fluent in English and a regional Language, if applicable
- Required Skills:
- Business Process Modeling, Change Management, Communication Strategy Development, Digital Strategy, Pharmaceutical Manufacturing, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions
- Preferred Skills:
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- Search Firm Representatives Please Read Carefully
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
- Employee Status:
- Regular