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 .