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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Associate - Reg Affiliate - Labeling VAR coordination
Job ID R0000039399 , MexicoRegulatory Affairs Associate (Labeling Variations coordination) 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.
Key Accountabilities:
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 led 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.
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