At a Glance
- Tasks: Lead regulatory operations and drive innovation in the EU and EEMEA regions.
- Company: Join MSD, a global leader in medical advancements and innovation.
- Benefits: Enjoy flexible work arrangements and a diverse, inclusive workplace culture.
- Why this job: Make a meaningful impact on global health while collaborating with talented teams.
- Qualifications: Bachelor's degree in science or IT; experience in regulatory affairs required.
- Other info: Opportunity to work in London or Brussels with a focus on digital strategy.
The predicted salary is between 43200 - 72000 £ per year.
Director SPRI (System Process Regulatory Innovation), EU & EEMEA Regional Regulatory Operations (Multiple locations)
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Director SPRI (System Process Regulatory Innovation), EU & EEMEA Regional Regulatory Operations (Multiple locations)
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Join to apply for the Director SPRI (System Process Regulatory Innovation), EU & EEMEA Regional Regulatory Operations (Multiple locations) role at MSD in the UK
Job Description
We are recruiting for an exciting role for a
Job Description
We are recruiting for an exciting role for a Director SPRI EU & EEMEA Regulatory Operations to be based in either London or Brussels.
You will report to the Executive Director, Regional Regulatory Operations Lead, EU + EEMEA, leading a team approximately 6 FTEs (~3 direct reports) and contractors.
What You Will Do
- You will lead EU + EEMEA regional activities in support of the RIIM (Regulatory Innovation and Information Management) led Global Regulatory Affairs Clinical Safety (GRACS) Digital Strategy (DS) projects and systems.
- You will be responsible for partnering closely with key EU +EEMEA stakeholders to ensure the successful regional implementation of GRACS systems and to support continuous improvement of related business process activities.
- You will collaborate effectively with other SPRI regional teams, and key regional stakeholders to drive the strategic direction of the EU + EEMEA SPRI team and direct their teams to meet the current and anticipated business needs.
- You will ensure that regional needs are understood and translated into the requirements for the successful enablement of the applicable capabilities and are communicated clearly to regional stakeholders. This role will represent your region in the global project activities and lead the regional SPRI team in managing and completing the regional tasks.
- You will contribute to regional discussions and help contribute to global harmonisation efforts wherever applicable.
- When a particular change only affects the EU + EEMEA region, you will be responsible for leading and directing the overall team to meet the project objectives and deliverables, supporting local business and regulatory strategy activities as required.
Primary Activities Include But Are Not Limited To
- People Manager for the SPRI FTEs staff providing strong team leadership; organize and oversee the work of contract and outsourced resources as per business needs.
- In partnership with RIIM and other SPRI leaders, work cross functionally and cross regionally to drive a flexible capability support model for GRACS systems and tools.
- Organize and facilitate SPRI team’s interactions among RRO (across regions) and in partnership with RIIM to align on urgent issues and ensure balanced workload across the regions.
- Lead regional inputs to global Digital Strategy projects, in agreement with the RIIM BSOs to ensure GRACS systems and tools evolve with the regional needs and landscape.
- Lead and manage the development, implementation and continuous improvement of the regional regulatory business processes and change management initiatives associated with GRACS systems and tools by collaborating with RIIM along with regional and country RA staff.
Education And Experience
- Bachelor’s degree in a science or information technology discipline required
- Substantial experience in Regulatory Affairs and/or Regulatory Operations, with at least some of this experience in implementing and/or supporting regulatory information systems (e.g., document management systems such as Documentum/Veeva, submission publishing tools such as InSight, regulatory health registration management tools such as Calyx).
- 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 information management strategies
- 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).
Skills/competencies
- Solid understanding of the regulatory activities that occur at the country and regional level as well as the requisite capabilities that enable that execution.
- Additionally, a broad understanding of the SDLC aspects associated with GRACS systems to effectively lead the SPRI team is preferred.
- Ability to prioritise their own work across several ongoing projects
- Ability to lead by influence and work effectively in matrix organizational structures
- Executive presence (for presentations/meetings)
- Attention to detail
- Excellent communication skills (verbal and written)
- Ability to prioritise team workload to deliver on the team’s objectives will be a key marker of success in this role.
- Proven decision-making skills in ambiguous situations
Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.
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 for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Closing date for applications 22nd August 2025
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)
Required Skills
Building Leadership Teams, Building Leadership Teams, Business, Business Processes, Business Process Management (BPM), Change Management, Contract Management, Cross-Functional Teamwork, Decision Making, Employee Training Programs, EU Legislation, Leadership, Management Process, Negotiation, People Leadership, Pharmacovigilance, Program Implementation, Project Implementations, Project Management System, Regional Management, Regulatory Compliance, Regulatory Experience, Regulatory Intelligence, Regulatory Strategies, Regulatory Strategy Development {+ 5 more}
Preferred Skills
Job Posting End Date
08/22/2025
- 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.
Requisition ID R358382
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research, Quality Assurance, and Science
-
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
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Director SPRI (System Process Regulatory Innovation), EU & EEMEA Regional Regulatory Operations[...] employer: MSD in the UK
Contact Detail:
MSD in the UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director SPRI (System Process Regulatory Innovation), EU & EEMEA Regional Regulatory Operations[...]
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in EU and EEMEA operations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in regulatory innovation.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and challenges faced in the EU and EEMEA regions. Understanding local nuances can set you apart as a candidate who is not only knowledgeable but also proactive in addressing regional needs.
✨Tip Number 3
Demonstrate your leadership skills by sharing examples of how you've successfully managed teams or projects in previous roles. Highlight your ability to influence and collaborate across different functions, as this is crucial for the Director role.
✨Tip Number 4
Stay updated on the latest developments in digital strategies related to regulatory affairs. Being well-versed in tools like Documentum, Veeva, and other regulatory information systems will show that you're ready to contribute to the company's goals from day one.
We think you need these skills to ace Director SPRI (System Process Regulatory Innovation), EU & EEMEA Regional Regulatory Operations[...]
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs and Operations. Emphasise your leadership skills and any project management methodologies you are familiar with, such as PMBok or Lean Six Sigma.
Craft a Compelling Cover Letter: In your cover letter, clearly articulate why you are interested in the Director SPRI role. Mention specific projects or experiences that align with the responsibilities outlined in the job description, showcasing your understanding of the EU + EEMEA regulatory landscape.
Highlight Key Skills: Focus on key competencies mentioned in the job description, such as communication skills, decision-making abilities, and experience with regulatory information systems. Use examples from your past roles to demonstrate these skills effectively.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for the role you are applying for.
How to prepare for a job interview at MSD in the UK
✨Understand the Role Thoroughly
Before your interview, make sure you have a deep understanding of the Director SPRI role and its responsibilities. Familiarise yourself with the key activities mentioned in the job description, such as leading regional activities and collaborating with stakeholders. This will help you articulate how your experience aligns with the role.
✨Showcase Your Leadership Skills
As this position involves managing a team, be prepared to discuss your leadership style and experiences. Share specific examples of how you've successfully led teams, managed projects, and navigated challenges in a regulatory environment. Highlight your ability to influence and motivate others.
✨Demonstrate Regulatory Knowledge
Given the focus on regulatory operations, it's crucial to demonstrate your expertise in this area. Be ready to discuss your experience with regulatory information systems and your understanding of the System Development Life Cycle. This will show that you are well-equipped to handle the technical aspects of the role.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving and decision-making skills in ambiguous situations. Think of examples from your past where you had to make tough decisions or lead a project under pressure. This will showcase your critical thinking and adaptability.