Regulatory Affairs Job at Parexel | Life Sciences | Remote Opportunity | Apply NowÂ
In the rapidly evolving landscape of global biopharmaceuticals, navigating the path to market approval requires precision, rigorous documentation, and strategic execution. For professionals based in Latin America (specifically Argentina, Brazil, or Mexico), this remote Regional Submission Coordinator role at Parexel Consulting is an exceptional Regulatory Affairs Job. It offers a highly sought-after opportunity to build a long-term Parexel career from the comfort of a home office, making it a standout Life Sciences Job for early-career regulatory specialists.
- Job Position: Regulatory Submission Coordinator
- Primary Location:Â Argentina, Remote
- Additional Locations:Â Brazil, Remote; Mexico, Remote
- Job ID:Â R0000039403
- Category:Â Regulatory Affairs
About The Company
Parexel is a global powerhouse in the clinical research and consulting space, dedicated to helping biopharmaceutical and medical device companies navigate complex, ever-changing regulatory environments. Choosing a Parexel career means joining a culture that values innovation, continuous learning, and cross-functional collaboration. As part of the consulting arm, you will not be limited to a single product or therapeutic area. Instead, you will partner with a diverse portfolio of clients, gaining exposure to various product types while receiving mentorship from senior regulatory professionals.
Key Responsibilities
As a Regional Submission Coordinator (Associate), you are the operational engine behind the regulatory strategy. You ensure that the documentation required by Health Authorities is accurate, compliant, and delivered strictly on time.
Submission Coordination & Execution
- Lifecycle Management (LCM): You will support the preparation and delivery of regulatory submissions according to the strategies defined by Regional Regulatory Leads (RRLs).
- Documentation Tracking: Coordinate, request, and track critical documentation from Subject Matter Experts (SMEs) to ensure submission readiness.
- Submission Content Plans: Assist in the preparation and maintenance of the Submission Content Plan (SCP) and manage the dispatch of non-eCTD submission packages.
Labeling Operational Support
- Artwork & Mock-ups: Initiate and coordinate mock-up requests within the Artwork Management System, tracking print releases for local labeling updates.
- Annotated Documents: Prepare annotated labeling documents for regulatory review, ensuring all changes are accurately tracked and archived.
Regulatory Systems Management
- Data Integrity: You will be responsible for creating and maintaining accurate regulatory records in enterprise systems like Veeva RIMS and Apollo.
- Health Authority Interactions: Update internal systems with questions and feedback received from local Health Authorities, ensuring complete traceability in DocNet.
Qualifications & Skills Required For Regulatory Affairs Job
This Regulatory Affairs Job is tailored for early-career professionals who possess a strong foundational understanding of regulatory operations and exceptional organizational agility.
- Educational Foundation: A Bachelor’s degree in Life Sciences or a closely related discipline is required.
- Industry Experience: You need 1 to 3 years of hands-on experience in regulatory affairs, regulatory operations, or a related biotech/pharma role.
- Linguistic Mastery: Because this role spans regional operations, effective written and verbal communication skills in both English and Spanish are strictly mandatory.
- Technical Proficiency: Experience or familiarity with Regulatory Information Management Systems (like Veeva RIMS) and document management tools is highly desired.
- Work Style: You must be highly detail-oriented, adaptable in a fast-paced matrix environment, and possess a strong service mindset to support cross-functional stakeholders effectively.
In summary, the Regional Submission Coordinator role is a definitive Life Sciences Job for professionals ready to master the operational side of drug approvals. By securing this remote Regulatory Affairs Job in Argentina, Brazil, or Mexico, you are positioning yourself at the center of global pharmaceutical compliance. If you have the required bilingual communication skills and a meticulous eye for regulatory documentation, launching your Parexel career here will provide the exact challenging assignments and mentorship needed to accelerate your professional trajectory.
