Parexel Regulatory Submissions Associate/Senior Associate (Biological products) Recruitment 2026: Apply Online for Various Vacancies
Regulatory Submissions Associate / Senior Associate (Biological products)
Job Overview
About the Role and Impact
Parexel is currently seeking a highly motivated and detail-oriented professional to join our global consulting team as a Regulatory Submissions Associate or Senior Associate, specializing in Biological Products. This remote position based in Mexico offers a unique opportunity to work at the forefront of clinical research and drug development. In this role, you will be instrumental in helping biopharmaceutical and medical device companies navigate the complex, rapidly evolving global regulatory landscape. By leveraging your scientific, technical, and regulatory expertise, you will collaborate closely with clients and internal stakeholders to execute and coordinate regulatory submissions, ensuring life-saving therapies reach patients faster and remain compliant on the market.
Key Areas of Focus
The successful candidate will support the execution and coordination of regulatory submission and labeling activities across assigned countries within a specific region. Reporting directly to the Regional Submission Coordinator (Lead), this role focuses heavily on operational delivery, documentation coordination, system updates, and labeling execution. You will work in close partnership with Regional Regulatory Leads (RRLs), Local Regulatory Responsibles (LRRs), Regulatory Partner Representatives (RPRs), and various cross-functional stakeholders. The position is structured at two levels to accommodate different experience brackets: the Associate level (1–3 years of experience) and the Senior Associate level (3+ years of experience).
Detailed Responsibilities
- Submission Coordination & Operational Support: You will coordinate, prepare, and deliver regulatory submissions and lifecycle management (LCM) activities. This includes organizing submission team meetings, tracking action items, and requesting documentation from Subject Matter Experts (SMEs) to ensure submission readiness.
- Labeling Operational Support: Perform hands-on operational support for labeling activities, prepare annotated labeling documents for regulatory review, initiate mock-up requests in the Artwork Management System, and manage change control activities related to local labeling updates.
- Regulatory Systems & Documentation: Maintain the accuracy of submission and regulatory records in systems such as Veeva RIMS and Apollo. You will upload Module 1 and non-eCTD submission documents to DocNet, ensuring completeness and traceability.
- Project Support & Communication: Provide regular status updates to the Regional Submission Coordinator Lead, track milestones, and escalate operational issues or delays with proposed mitigation actions.
- Quality & Compliance: Ensure all activities comply with applicable SOPs, work instructions, and regional regulatory requirements, maintaining inspection readiness at all times.
Why Join Parexel?
At Parexel, we thrive on collaboration, caring, and inclusivity. We offer a supportive environment where you can balance your personal and professional responsibilities through our flexible remote work arrangements. Working with a global network of colleagues, you will gain exposure to diverse product types and therapeutic areas, with ample opportunities for career growth, learning, and mentorship from highly experienced regulatory professionals. Our patient-centric culture ensures that everything we do is inspired by the patients behind the data, driving us to deliver first-time quality and on-time projects.
The Importance of Biological Products Expertise
Biological products represent some of the most complex and innovative therapies in modern medicine, including vaccines, gene therapies, and monoclonal antibodies. Navigating the regulatory pathways for biologics requires a specialized understanding of their unique manufacturing processes, stability profiles, and clinical evaluation standards. In this role, your mandatory experience with biological products will be critical as you manage the intricate documentation and specific health authority requirements associated with these advanced therapies. Your expertise will directly contribute to the successful lifecycle management and market availability of these vital treatments.
Bilingual Communication Requirements
As a remote professional based in Mexico supporting regional and global operations, seamless communication is paramount. This role requires mandatory bilingual proficiency in both English and Spanish. You will be drafting annotated labeling documents, communicating with local regulatory representatives across different countries, and collaborating with global subject matter experts. Clear, precise, and professional communication in both languages ensures that regulatory submissions are accurate, misunderstandings are minimized, and timelines are met efficiently.
Key Job Details
| Company Name | Parexel |
| Job Role | Regulatory Submissions Associate / Senior Associate (Biological products) |
| Experience | Associate: 1–3 years; Senior Associate: 3+ years |
| Salary Range | Not Disclosed |
| Job Category | Graduation Jobs, Private Jobs |
| Job Type | Full Time |
| Work Mode | Remote |
| Openings | Various |
| Job Location | Mexico (Remote) |
Key Responsibilities
- Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities.
- Assist in organizing submission team meetings and follow up on agreed actions.
- Coordinate, request, and track documentation from Subject Matter Experts (SMEs).
- Support the preparation and maintenance of the Submission Content Plan (SCP).
- Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs.
- Provide hands-on operational support for labeling activities.
- Prepare annotated labeling documents for regulatory review.
- Initiate and coordinate mock-up requests in the Artwork Management System.
- Support the creation, maintenance, and accuracy of submission and regulatory records in systems like Veeva RIMS and Apollo.
- Upload Module 1 and non-eCTD submission documents to DocNet.
Requirements & Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
- 1–3 years of experience for Associate level, or 3+ years for Senior Associate level in regulatory affairs/operations.
- Mandatory experience working with Biological Products.
- Mandatory bilingual proficiency in English and Spanish (written and verbal).
- Proficiency in using Veeva RIM and document management tools.
Required Skills
- Experience with Biological Products (Mandatory)
- Experience with Veeva RIM 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)
- Good understanding of regulatory submission processes and lifecycle management activities
About Parexel
Parexel is a leading clinical research organization (CRO) providing comprehensive services to the pharmaceutical, biotechnology, and medical device industries.
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