Specialist, Regional Submission Planning

San José
Permanente
Tiempo completo

Hace 22 horas

Job DescriptionSpecialist Regional Submission PlannerThe Regional Submissions Planner will work within the Company´s Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations department (RRO), supporting regional planning activities for the LATAM region while also contributing to cross-regional planning activities as needed. The Regional Submission Planner will support the regulatory submission plan creation and registration tracking of the company’s regulatory submission targets from a regional and cross-regional operational perspective.This role works closely with various stakeholders to drive the identification, planning, execution, and management of activities to deliver high quality and timely regulatory and safety submissions for approval. The incumbent is expected to demonstrate strong project management skills with the ability to operate in a multicultural environment and experience working in a cross-functional setting. Should be capable of independent management of all submission plans and documentation, at any level of complexity, across all submission types throughout the product lifecycle. Additionally, the incumbent may be involved in supporting internal or external process improvement or strategic initiatives.Core Responsibilities:Plan, coordinate and review regional regulatory submissions, ensuring compliance with internal and external requirements for timely delivery to the Health Authorities.Develop and maintain regulatory submission plans for the assigned programs/products ensuring alignment with milestones and deadlines.Facilitate and participate in cross-functional meetings to ensure smooth planning, execution and communication of regulatory submission activities.Drive the submission assembly and delivery process in collaboration with the Submission Publisher ensuring all submissions meet quality and timelines expectations.Manage and maintain regulatory systems and databases to support submission tracking, reporting and compliance needs.Continuously identify and implement process improvements to enhance efficiency and streamline submission activities. Participate in process improvement projects.Maintain a robust understanding of regulatory requirements, leveraging this knowledge to support the planning and execution of submissions across regions.Collaborate with internal and external stakeholders to ensure alignment and successful execution of submission deliverables.Support cross-regional activities by participating in initiatives or projects that involve multiple regions.Support strategic initiatives related to the submissions process such as technology enhancements and process optimization.Maintain knowledge of regulatory processes within LATAM and other regions as needed.Qualifications:Bachelor’s degree in a Life Science, Pharmacy or Engineering related discipline.At least 2 years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs.Strong written and oral communication skills in English.Desired Skills:Effective problem solving and critical thinking with ability to analyze, strategize, and find creative solutions to navigate complex regulatory landscapes and make informed decisions.Adaptable with the ability to adjust, modify, or change one's approach, behavior, mindset and/or plan in response to evolving priorities.Ability to collaborate, interact, and negotiate effectively with internal and external stakeholders in cross-functional and multicultural environments.Ability to communicate effectively, both verbally and in writing across levels and functional areas within the organization.Strong time management and detail orientation to support submissions planning and execution of projects/programs.Team facilitation skills with the ability to establish collaborative environments and drive alignment across deliverables.Working knowledge of regulatory guidelines, procedures and processes, especially within the LATAM region.Ability to maintain oversight in the coordination and execution of planning, tracking, assembling, and delivering regulatory components in alignment with regulatory strategy and compliance.Experience in project management methodologies with the ability to handle multiple tasks and prioritize effectively.Familiarity with complex regulatory IT systems.Current Employees applyCurrent Contingent Workers applySearch 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: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): noRequired Skills: Adaptability, Adaptability, Communication, Detail-Oriented, Diversity Management, Electronic Common Technical Document (eCTD), Employee Training Programs, Internal Compliance, Microsoft Office, Multi-Management, Pharmaceutical Management, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Problem Solving, Process Improvement Projects, Process Improvements, Project Management, Project Support, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Project Management, Regulatory Reporting {+ 5 more}Preferred Skills:Job Posting End Date: 09/14/2025*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.

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