Regulatory Affairs Associate is responsible for managing labeling ensuring that biological product labels, artwork, translation and packaging components comply with the regulatory requirements of each Local country. The role supports marketing authorization submissions, lifecycle management, and post approval variations requiring labeling updates.

A. Labeling & Artwork Management
- Prepare, review, and update product labeling according to requirements from Health authorities
- Ensure localized labeling content (language, warnings, dosage, contraindications) complies with each country’s standards.
- Coordinate artwork development and version control with internal teams and external vendors.

B. Regulatory Submissions
- Support Marketing Authorization Applications (MAAs), renewals, and variations that involve labeling changes.
- Prepare labeling sections of the dossier per local format (CTD/eCTD with country‑specific annexes)

C. Cross‑Functional Collaboration
- Work closely with RA, QA, supply chain, artwork teams, and local affiliates to ensure labeling accuracy and timely updates.




- Act as liaison between integral teams and local representatives.

Business Development
- Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
- Communicates potential new business lead to PC management and account managers

Parexel-related Activities
- Meets established metrics as specified in scorecard on an annual basis
- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects
- Defines self-development activities with the support of management in order to keep current within the industry

Skills:
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Excellent interpersonal and intercultural communication skills,

📌 Regulatory Affairs Associate (Buenos Aires)
🏢 Parexel
📍 Buenos Aires