パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Regulatory Affairs Associate - Labeling / Marketing Application
応募 求人ID R0000039403 ロケーション アルゼンチン共和国 仕事内容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 global 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, both written and verbal
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language
Knowledge and Experience:
Initial years of experience in an industry-related environment
Education:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
