Regulatory Affairs Associate MAA
Mexico, Remote Job ID R0000027653 Category Regulatory / Consulting Date Posted 09/17/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We are looking for a Regulatory Affairs Associate or Associate with 1 or 2 years of experience in MAA y MTA (marketing authorization application y marketing authorization transfers) preferably developed in CROs.
This role's main activities will be:
- Dossier management including MA submission and MA renewals.
- Perform new dossiers for new marketing authorizations (local or international).
- Handling of documentation for marketing authorization renewals and artwork managing.
- Review SmPCs and PSURs.
- Communication with local HA and clients.
- Respond to any observation from clients or local HA.
- Client facing position.
- Good English skills.
#LI-REMOTE
Employee Insights
Why Consultants work at Parexel
