CW-Regulatory Affairs Associate/Senior Associate

Career Category

Corporate Services

Job Description

Job Summary

• •Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
• •Execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
• •Coordination and execution of Regulatory Affairs processes and deliverables in the local office.

Responsibility:

• •Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.
• •Creates and reviews source text for country labeling.
• •Reviews promotional and non-promotional materials.
• •Coordinates translation for local Regulatory submission,
• •Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
• •Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all company molecules.
• •Partners with peers to ensure consistency on procedures
• •Assists locally in Healthcare Compliance activities, where applicable.
• •Participates in local regulatory process improvements, initiatives and training.
• •Oversees external vendor/contractor relationships, where applicable.

Requirements:

• •Bachelor’s degree in scientific area or related
• •Knowledge of Regulatory principles.
• •Working with policies, procedures and SOP’s.
• •Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• •Understanding of drug development.
• •Demonstrate ability to work in teams.
• •Ability to understand and communicate scientific/clinical information

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