Senior Regulatory Labeling Specialist — Europe (Remote)

Parexel; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs Associate or Senior Regulatory Affairs Associate to draft, maintain, and manage core labelling documents across multiple markets. The role supports lifecycle activities, ensures consistency, and upholds high standards of quality and compliance in regulatory labelling.

The successful candidate will work on CCDSs, SmPCs, and prescribing information, collaborating with cross-functional teams to ensure alignment with global and local requirements.

Qualifications

• Experience in Regulatory Affairs, pharmaceutical labelling, or technical authoring.
• Knowledge of labelling structure, content, and maintenance.
• GDP and quality management principles understanding.
• Excellent communication and stakeholder management skills.
• Fluent in English, written and spoken.

Responsibilities

• Draft, maintain, and manage core labelling documents (CCDSs, SmPCs, package leaflets, prescribing information).
• Ensure consistency across global and local labelling; apply regulatory guidelines.
• Support lifecycle activities and regulatory variations across markets.
• Maintain document quality and traceability with change management.

Skills

Regulatory Affairs

Labelling

Documentation

English fluency

Education

Life Sciences degree

Job description

Parexel is seeking a Regulatory Affairs Associate or Senior Regulatory Affairs Associate to draft, maintain, and manage core labelling documents across multiple markets. The role supports lifecycle activities, ensures consistency, and upholds high standards of quality and compliance in regulatory labelling.

The successful candidate will work on CCDSs, SmPCs, and prescribing information, collaborating with cross-functional teams to ensure alignment with global and local requirements.