CW-Regulatory Affairs Associate/Senior Associate

<h2><b>Career Category</b></h2>Corporate Services<h2></h2><h2><b>Job Description</b></h2><p><span><b><span>Job Summary</span></b></span></p><ul><li><span><span>Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.</span></span></li><li><span><span>Execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.</span></span></li><li><span><span>Coordination and execution of Regulatory Affairs processes and deliverables in the local office.</span></span></li></ul><p><span><b><span>Responsibility:</span></b></span></p><ul><li><span><span>Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.</span></span></li><li><span><span>Creates and reviews source text for country labeling.</span></span></li><li><span><span>Reviews promotional and non-promotional materials.</span></span></li><li><span><span>Coordinates translation for local Regulatory submission,</span></span></li><li><span><span>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.</span></span></li><li><span><span>Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all company molecules.</span></span></li><li><span><span>Partners with peers to ensure consistency on procedures</span></span></li><li><span><span>Assists locally in Healthcare Compliance activities, where applicable.</span></span></li><li><span><span>Participates in local regulatory process improvements, initiatives and training.</span></span></li><li><span><span>Oversees external vendor/contractor relationships, where applicable.</span></span></li></ul><p><span><b><span>Requirements:</span></b></span></p><ul><li><span><span>Bachelor’s degree in scientific area or related</span></span></li><li><span><span>Knowledge of Regulatory principles.</span></span></li><li><span><span>Working with policies, procedures and SOP’s.</span></span></li><li><span><span>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</span></span></li><li><span><span>Understanding of drug development.</span></span></li><li><span><span>Demonstrate ability to work in teams.</span></span></li><li><span><span>Ability to understand and communicate scientific/clinical information</span></span></li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.