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
