When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Regional Submission Coordinator – AssociatePosition OverviewThe Regional Submission Coordinator – Associate - supports the execution and coordination of regulatory submission and labeling activities across assigned countries within a region. Reporting to the Regional Submission Coordinator (Lead), this role focuses on operational delivery, documentation coordination, system updates, and labeling execution to ensure timely, compliant, and high-quality regulatory submissions. The Associate works in close collaboration with the Lead, Regional Regulatory Leads (RRLs), Local Regulatory Responsibles (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders.
Key Responsibilities – Submission Coordination & Operational Support• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead).
• Assist in organizing submission team meetings (e.g., Kick-off Meetings) and follow up on agreed actions.
• Coordinate, request, and track documentation from Subject Matter Experts (SMEs) to support submission readiness and timelines.
• Support the preparation and maintenance of the Submission Content Plan (SCP) under the guidance of the RSC Lead.
• Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs and track dispatched documentation per country.
Key Responsibilities – Labeling Operational Support• Provide hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC Lead.
• Prepare annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs.
• Initiate and coordinate mock-up requests in the Artwork Management System.
• Track print releases as required.
• Support change control activities related to local labeling updates.
• Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet.
Key Responsibilities – Regulatory Systems & Documentation• Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo).
• Upload Module 1 and non-eCTD submission documents to DocNet and ensure completeness and traceability.
• Update regulatory systems with Health Authority interactions, including uploading questions received from Health Authorities in the appropriate records.
• Support data quality and consistency across systems and documentation repositories.
Project Support & Communication• Provide regular status updates to the Regional Submission Coordinator (Lead) on assigned activities, timelines, and potential issues.
• Support tracking of submission milestones, deliverables, and dependencies.
• Escalate operational issues or delays to the RSC Lead with appropriate context and proposed mitigation actions.
• Collaborate effectively with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders.
Quality & Compliance• Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements.
• Support inspection readiness by ensuring accurate, complete, and well-organized submission and labeling documentation.
• Maintain awareness of regional regulatory processes relevant to assigned activities and follow guidance provided by the Lead and RRLs.
Required Qualifications• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
• 1–3 years of experience in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role.
• Good understanding of regulatory submission processes and lifecycle management activities.
• Experience or familiarity with regulatory information management systems (e.g., Veeva RIMS) and document management tools.
• Strong organizational skills with attention to detail and quality.
• Ability to manage multiple tasks and timelines in a matrix environment.
• Effective written and verbal communication skills in English and Spanish (mandatory)
Key CompetenciesTechnical Competencies:
• Regulatory submission documentation and coordination
• Labeling operational support and artwork coordination
• Regulatory systems and data management
Professional & Behavioral Competencies:
• Attention to detail and quality orientation
• Strong organizational and follow-up skills
• Collaborative mindset and stakeholder support
• Adaptability in a fast-paced, cross-regional environment
• Team-oriented approach with a service mindset
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
-
Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
-
Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
-
Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
Similar Jobs
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
