I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate
Primary Location: Brazil, Remote Job ID R0000037324 Category Regulatory Affairs Date Posted 12/19/2025Overview
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
The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control assessments, and ensuring compliance with regulatory requirements across multiple regions. The role requires strong technical regulatory expertise, excellent writing skills, and the ability to evaluate scientific CMC information for accuracy. A degree in biological or health sciences (Regulatory Affairs preferred) and at least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry are essential.
Activities:
Author global CMC variation submissions (m1/2/3), including responses to HA requests.
Author CMC components for annual reports and renewals (m1/2/3), including responses to HA requests.
Author CMC components for global MAA (m1/2/3) rollouts (post 1st wave approvals), including responses to HA requests.
Author CMC components for tender applications (m1/2/3).
Support CMC GMP submissions, e.g., site registrations.
Change control assessments (Client to assess major impact countries, vendor to assess impact for all other countries).
Confirm CMC requirements for submission e.g. variation, renewal, tender, etc.
Align with the client (information flow to be defined) on technical information to be provided and timelines.
Preparation of the CMC packages.
Provide packages for internal client review and update these as needed.
Provide finalized packages for publishing and QC published output.
Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed.
Support requests for information from HAs or from affiliates/partners.
Complete change control assessments for non-major impact countries.
Education:
University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD).
Degree in Regulatory Affairs is advantageous, but not mandatory.
Experience:
Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC.
Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products.
Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia).
Strong regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.
Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
#LI-REMOTE
Employee Insights
Why Consultants work at Parexel
