Job Description
Senior Specialist, System Process & Regulatory Innovation (SPRI)
The Senior Specialist, SPRI supports the regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
The role focuses on regulatory content and submission management, submission planning and execution, and regulatory information/health registration systems.
You will work across all countries in the region, partnering with Regulatory Innovation & Information Management (RIIM), Business System Owners (BSOs), Business Process Owners (BPOs), and key regional stakeholders to ensure systems meet regional and country-specific needs, and that processes and capabilities are continuously improved.
Digital skills (e.g., Microsoft Power Platform, Gen AI) and a strong interest in regulatory technology and process excellence are highly valued.
What You Will Do:
- Support regional implementation, adoption, and enhancement of GRACS regulatory systems and digital capabilities.
- Act as primary contact (or secondary support) for regional users on system usage, business processes, and process improvement initiatives; provide user training as needed.
- Understand underlying business processes; work with BPOs to adapt procedures to regional and local regulatory requirements.
- Evaluate regional data, identify data quality and compliance issues, and develop/implement action plans.
- Ensure timely regional input and delivery of tasks for global projects.
- Contribute to regional and global projects that enable regulatory and business strategies, particularly those involving process digitization and automation.
- Collaborate with RAI, iCMC, GRACS O.P.S, PV, and other GRACS functions to deliver regional objectives.
- Translate regional needs and external changes into actionable plans aligned with the GRACS Digital Strategy; support communications and change management activities.
- Provide direct support for GRACS RIIM tools: promote good data management practices, deploy automations for standardized tasks, and support system–process improvement collaborations.
- Organize/participate in regional communication forums to share updates on processes and system changes.
- Represent regional needs in Change Control Boards and Communities of Practice.
- Support development and delivery of global/regional regulatory training and refresher sessions.
- Provide periodic operational metrics and dashboards; report progress on regional objectives and strategic initiatives.
- Work with other Regional SPRI staff to align activities, share best practices, and identify automation-based solutions.
What You Must Have:
Education
- Bachelor’s degree in a science, information technology, Pharmacy, or related discipline required.
- Advanced degree (engineering or scientific discipline, MBA) preferred.
Required Experience & Skills
- With around 2–4 years’ experience in Regulatory Affairs, Regulatory Operations, and/or pharmaceutical manufacturing, with at least 3 years’ experience implementing and/or supporting regulatory information systems.
- Demonstrated ability to lead and influence without direct authority; strong organizational awareness.
- Ability to prioritize and manage work across multiple concurrent projects.
- Proven problem-solving skills; experience analyzing information and implementing actions to improve data quality, processes, or systems.
- Experience in project management methodologies, change management, process re-engineering, analytics and reporting (e.g., Cognos, PowerApps, ChatGPT), training material development, and communications is beneficial.
- Strong critical thinking, collaboration, Communication and stakeholder engagement skills.
Language
- Fluent in English; fluency in a relevant regional language is an advantage.
**Required Skills: **
Automation Technology, Automation Technology, Business Management, Business Processes, Business Process Management (BPM), Business Process Modeling, Business Systems, Change Catalyst, Communication, Content Management, Critical Thinking, Customer Service, Dashboard Reporting, Data Quality, Data Visualization, Digital Strategy, Drafting Agreements, Operational Metrics, Ownership and Accountability, Pharmacovigilance, Process Improvements, Project Management, Regional Management, Regulatory Affairs Compliance, Regulatory Affairs Management {+ 3 more}
**Preferred Skills: **
Change Controls, Change Management, Training and Development, Waterfall Model
Current Employees apply HERE
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: **
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
04/20/2026
***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. **