- Location
- MYS - Selangor - Petaling Jaya (Ascent Paradigm), Malaysia · PHL - Philippines - Philippines
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Legal
- Experience
- 3+ years
- Closing date
- Today
- Source
- Workday
Description
Job Description
The Senior Specialist, Regional System Process & Regulatory Innovation (SPRI) is an individual contributor within the Regional Regulatory Operations – Asia Pacific (RRO AP) department, part of our company’s Global Regulatory Affairs and Clinical Safety (GRACS) organization.
This role is responsible for the operational execution and support of regulatory systems, processes, and digital initiatives across the APAC region, while progressively expanding exposure to regional strategy and governance activities within established frameworks.
The Senior Specialist applies technical and functional knowledge of regulatory systems and business processes and works closely with Regulatory Innovation & Information Management (RIIM), Business System Owners (BSOs), and key regional stakeholders to deliver assigned system-related activities and project workstreams.
In addition to core delivery responsibilities, this role contributes to selected regional initiatives, governance activities, and strategic inputs under guidance, supporting alignment with global and regional priorities. The Senior Specialist will progressively build capability in identifying improvement opportunities and supporting change initiatives, while maintaining accountability for execution, data quality, and compliance within defined governance structures.
All activities are performed under established procedures, defined governance, and within regional and global system and process frameworks.
Key Responsibilities
Execute and own delivery of assigned system, process, and data-related activities and initiatives end-to-end, including day-to-day operations, project workstreams, and defined improvement efforts.
Ensure timely execution, stakeholder alignment, and adherence to governance and compliance requirements.
Provide end-user support and enablement across regulatory systems and processes, including:
Handling inquiries
Supporting data entry and process adherence
Contributing to training and communication materials
Promoting consistent and compliant system usage across the region
Drive data quality and continuous improvement activities, including:
Monitoring and root cause analysis
Implementing corrective actions
Identifying opportunities to enhance workflows, documentation, system usage, and data integrity
Support system implementation, enhancements, and change activities, including:
Preparation of deliverables
Testing, validation, and user acceptance
Documentation updates
Execution of defined changes to ensure adoption
Contribute to governance and strategy activities within defined scope, including:
Preparing regional inputs
Participating in governance forums
Providing data-driven insights for decision-making under guidance
Represent the region in selected forums, working groups, or communication platforms as assigned
Collaborate with SPRI colleagues and cross-functional stakeholders to:
Align activities
Share best practices
Support regional goals
Identify automation and optimization opportunities
Role Scope
Individual contributor role
No formal people management responsibilities
No budget ownership
No accountability for regional strategy
Education
Bachelor’s degree in Science, Information Technology, Pharmacy, or a related discipline required
Required Experience & Skills
Minimum 3 years of experience in:
Regulatory Affairs
Regulatory Operations
System/process-related roles supporting regulatory systems and digital initiatives
Working knowledge of regulatory business processes, including:
Submission planning and execution
Regulatory information management
Experience in:
System implementation
Testing and validation
User support activities
Ability to manage multiple tasks and priorities in a matrix environment
Strong communication and collaboration skills to engage with regional and cross-functional stakeholders
Experience in:
Data quality initiatives
Process improvement
System enhancements
Preferred
Experience in:
Project management methodologies
Change management
Process re-engineering
Analytics and reporting tools (e.g., Cognos, PowerApps, ChatGPT)
Training material development and communication strategies
Language Requirements
Fluent in English
Required Skills:
Academic Quality Improvement Program (AQIP), Academic Quality Improvement Program (AQIP), Adaptability, Audits Compliance, Business Processes, Business Systems, Change Management, Collaborative Communications, Corrective Action Management, Data Integrity, Data Quality Control, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Information Management, Operational Execution, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations {+ 2 more}Preferred Skills:
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Current Contingent Workers apply HERE
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/26/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
