Job Description

Are you a detail-oriented regulatory professional with strong project management and leadership skills? We are seeking a highly experienced Regional Submissions Planner to join our Global Regulatory Affairs and Clinical Safety (GRACS) organisation. As a member of our Regulatory Affairs Operations International team based in Europe, you will play a pivotal role in supporting the creation and tracking of regulatory submissions across the Europe, Middle East, and Africa (EMEA) region. Responsibilities:

• Provide strong project management leadership for regulatory submissions planning within the region, collaborating with other planning teams both within and outside of the region.
• Plan and manage regulatory operation projects, ensuring authorization through delivery to country regulatory affairs teams and/or Health Authorities.
• Develop and maintain a tactical approach for dedicated programs, identifying opportunities to optimize processes and resource allocation.
• Create and maintain the regulatory submission plan for assigned projects/products, along with related project milestones in collaboration with other regional planners.
• Work closely with the central planner based in the headquarters (US) on assigned projects/products.
• Drive the submission assembly and delivery process, ensuring timely assembly, publishing, and archival of assigned products/submissions as per agreed timelines in coordination with the Global and/or Regional Submission Publishing team.
• Lead or participate in cross-functional forums and meetings to support collaboration and knowledge sharing.
• Lead and collaborate on projects to improve the efficiency of the submission process and submission planning tools, taking on large-scale process improvement initiatives.
• Collaborate with other operational and project management groups within GRACS and across division(s) to share best practices and ensure effective project deliverables.
• Contribute to the development of training curriculum, mentoring and coaching new and junior team members or interns, and generating supportive materials for the team.
• Contribute to interactions with external regional planner partner teams and contribute to KPI reporting.
• Access and maintain regulatory systems and databases to fulfill daily functions.
• Stay updated on regional regulatory procedures, internal and external guidelines, and standards.

Requirements:

• Bachelor\xe2\x80\x99s degree in a Life Science-related discipline.
• Minimum of 5 years of experience in the regulatory operations area, preferably with a background in regulatory affairs.
• Certification in project management methodology (e.g., CPM, PMP, Six Sigma, Change Management, Prince 2, etc.) and associated toolsets (e.g., MS Project for project planning, MS Excel for data analysis and reporting), with at least 2 years of applied experience in project management.
• Effective negotiating, mentoring, and coaching skills within a team/project setting, with excellent communication and leadership skills to manage interactions with colleagues and stakeholders in a multicultural environment.
• Ability to handle time pressure and the consequences of any delay in timely submissions.
• Thorough knowledge of regulatory guidelines and procedures within the EMEA region.
• Affinity to work with complex IT systems.

Why Join Us:

• Opportunity to work within a global organization that values regulatory excellence and continuous improvement.
• Collaborative and inclusive working environment, fostering professional growth and development.
• Chance to make a significant impact on the regulatory landscape in the EMEA region.
• Competitive salary and comprehensive benefits package.

If you are a highly motivated and experienced regulatory professional with exceptional project management and leadership abilities, we would love to have you join our dynamic team! Apply now to embark on an exciting career journey with us. 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: Shift: Valid Driving License: Hazardous Material(s):
Requisition ID:R270160