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Full-time
bachelor degree
Posted 1d ago
~40 hrs/week
Remote in Mexico
Responsibilities
Coordinate and execute regulatory submissions and labeling activities for biological products across assigned LATAM countries. Maintain regulatory systems and documentation while collaborating with cross-functional stakeholders to ensure compliant and timely delivery.
Requirements
Requires a Bachelor's degree in Life Sciences or Pharmacy and experience with biological products and Veeva RIM. Must be fluent in English and Spanish and based in Mexico or Argentina.
Full job description
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.
About Parexel
Parexel is a leading clinical research organization providing comprehensive services to the pharmaceutical, biotechnology, and medical device industries. We are committed to advancing clinical research and bringing innovative therapies to patients worldwide. Our diverse team of professionals is dedicated to delivering excellence in regulatory affairs, clinical operations, and data management.
Regulatory Submission Coordinator – Sr Associate
About the Role
Join Parexel's Regulatory Affairs team as aRegulatory Submission Coordinatorand play a critical role in bringing innovative biological products to patients across Latin America. Reporting to the Regional Submission Coordinator Lead, you'll be the operational backbone of our regulatory submission process—coordinating complex documentation, managing timelines, and ensuring compliance across multiple countries in the LATAM region.
This is an opportunity to work at the heart of regulatory excellence, collaborating with regional regulatory teams, health authorities, and cross-functional stakeholders to deliver high-quality submissions that meet the highest standards.
The Opportunity
Sr Associate Level:4+ years of experience in Regulatory Submissions of Biological products (mandatory)
It is required to be based in México, Argentina or Brazil (Mandatory)
What You'll Do
Submission Coordination & Operational Support
Coordinate and support the preparation and delivery of regulatory submissions and lifecycle management activities across assigned LATAM countries
Organize and facilitate submission team meetings (Kick-off Meetings, etc.) and track action items
Request, coordinate, and track documentation from Subject Matter Experts to ensure submission readiness
Prepare and maintain Submission Content Plans under guidance of the RSC Lead
Ensure timely dispatch of submission packages to Local Regulatory Representatives and Regulatory Partner Representatives
Labeling Operational Support
Execute hands-on labeling activities, including preparation of annotated documents for regulatory review
Initiate and coordinate mock-up requests in the Artwork Management System
Track print releases and support change control activities for local labeling updates
Archive labeling documentation and ensure approved labeling is accurately stored in DocNet
Regulatory Systems & Documentation
Create, maintain, and ensure accuracy of submission records in regulatory systems (Veeva RIMS, Apollo)
Upload Module 1 and non-eCTD documents to DocNet with full traceability
Update regulatory systems with Health Authority interactions and regulatory correspondence
Maintain data quality and consistency across systems and repositories
Project Support & Communication
Provide regular status updates on assigned activities, timelines, and potential issues
Track submission milestones, deliverables, and dependencies
Escalate operational issues with context and proposed mitigation actions
Collaborate effectively with CMC, labeling, quality, and regulatory teams
Quality & Compliance
Execute all activities in compliance with SOPs, work instructions, and regional regulatory requirements
Support inspection readiness through accurate, complete, and well-organized documentation
Maintain awareness of regional regulatory processes and follow guidance from the RSC Lead and Regional Regulatory Leads
What We're Looking For
Mandatory Requirements:
Bachelor's degree in Life Sciences, Pharmacy, or related discipline
Experience with Biological Products(required)
Experience with regulatory submission processes and lifecycle management activities in LATAM
Proficiency with Veeva RIM and document management tools(required)
Fluent written and verbal communication in English
Based in Mexico or Argentina(required)
Key Competencies:
Strong organizational skills with meticulous attention to detail
Ability to manage multiple tasks and timelines in a matrix environment
Proactive problem-solver with strong communication skills
Collaborative team player with cross-functional experience
Detail-oriented with a commitment to quality and compliance
Why Join Parexel?
Impact:Contribute directly to bringing innovative biological therapies to patients across Latin America
Growth:Work with a leading CRO and develop expertise in regulatory affairs and submission management
Collaboration:Partner with talented regulatory professionals and cross-functional teams
Development:Access professional development and career advancement opportunities
Culture:Join a diverse, inclusive team committed to excellence in clinical research
Competitive Package:Competitive compensation and comprehensive benefits
Equal Opportunity
Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award.
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.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
Regulatory and product development consultingearly phase clinical researchphase II-III clinical researchlate phase clinical researcheClinical solutionspatient and site recruitmentmedical device consultingclinical research organizationpharmacovigilancebiotechnology
How many Science & Research jobs are open in Mexico, Mexico right now?
There are currently 49 open science & research positions in Mexico, Mexico listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Mexico, Mexico?
Companies currently hiring include Project Farma (PF), Precision Medicine Group, Abbott, Thermo Fisher Scientific, Parexel, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Mexico, Mexico?
Yes — 41 of the 49 open science & research positions offer remote or hybrid work (34 remote, 7 hybrid).
How do I apply for Science & Research jobs in Mexico, Mexico?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.