Regulatory Affairs Associate - Reg Affiliate - Labeling VAR coordination

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Regulatory 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.