Specialist Regional Submission Planner
Specialist Regional Submission Planner
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1 Vacancy
Job Description
Job Description
The Specialist Regional Submissions Planner will work within the our Global Regulatory Affairs and Clinical Safety (GRACS) organization in the Regional Regulatory Operations department (RRO) supporting regional planning activities for the EU EEMEA 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 companys 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 EU EEMEA and other regions as needed.
Qualifications:
- Bachelors 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 ones 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 EU EEMEA 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.
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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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Communication Detail-Oriented Diversity Management Electronic Common Technical Document (eCTD) Employee Training Programs Internal Compliance Management Process 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 4 morePreferred Skills:
Job Posting End Date:
09/4/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
