About this opportunity
Job Overview
Under general supervision, prepares and/or reviews regulatory submissions documents to support marketing authorization and post approval activities in Brazil for either internal and/or external clients. Provides regulatory support for assigned projects.
Essential Functions
Perform timely updates to regulatory databases following approvals, variations, renewals, extensions, and other lifecycle activities.
Manage the creation, review, and maintenance of regulatory documents and records in accordance with established procedures.
Support change control assessments by evaluating the regulatory impact of proposed product, manufacturing, labeling, and quality changes.
Collaborate with cross-functional teams, including Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Pharmacovigilance, to maintain current regulatory information.
Track and maintain regulatory commitments, submission milestones, and approval documentation.
Support preparation and maintenance of regulatory dossiers and lifecycle submissions.
Contribute to process improvements related to regulatory information management and document maintenance.
Ensure compliance with applicable regulatory requirements and internal quality standards.
Qualifications
Bachelor's Degree in Lifescience or related discipline.
At least 2 years’ relevant experience in:
1.- In lifecycle maintenance, including registration and post approval variations for synthetics and biological drug products in Brazil.
2.- Assessment, preparation and submission of post-registration as well as annual reports for synthetic and biological drug products.
3.- Submission of local legal documents for Health Authority and GMP certificate in Brazil. Submission of legal documents for CVS , VISA , COVISA , and ANVISA , as applicable. Development, review and submission of leaflet and labeling artwork related applications.
4.- In regulatory information systems, change control assessments.
5.- Hands-on experience with CADIFA, including maintenance of regulatory documentation, product records, and lifecycle management data
6.- Managing straight forward and lower complexity project activities with tight deadlines.
7.- Development, review and submission of leaflet and labeling artwork applications.
8.- Support in preparing assessments of national legislation, providing important and high-impact information for other areas. Participation in meetings with internal and external clients, in English, for providing regular project updates and discuss project's needs.
Fluent conversational English
Ability to work and collaborate effectively in a team environment and build positive working relationships across functions.
Demonstrated ability to build positive working relationships with colleagues and stakeholders.
Able to manage effectively multiple activities with tight deadlines, working with limited guidance and under senior staff supervision.
Ability to effectively manage competing priorities and respond to urgent business needs.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job details
How this role compares
Computed from every other active Clinical Development role in our database, not just this employer's listings.
We currently track 1427 comparable Clinical Development roles across 103 biopharma companies.
Salary context
461 of 1427 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1427 comparable roles
+ 48 more countries
Seniority mix
1016 of 1427 peers have a known seniority level
Therapeutic area mix
203 of 1427 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.