Regulatory Affairs Manager

<h2><b>Career Category</b></h2>Regulatory<h2></h2><h2><b>Job Description</b></h2><p><b>Regulatory Affairs Manager- China</b></p><p>Reporting to: Head of Regulatory Strategy, China RA</p><p>Based in: Beijing</p><p></p><p><b>Job Description</b></p><ul><li>Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.</li><li>Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.</li><li>Developing (with manager’s guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements</li><li>Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.</li><li>Participate in the local implementation of key Regulatory projects.</li><li>Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen pipeline.</li><li>Provide regulatory support for Therapeutic Areas/Scientific Affairs activities.</li><li>Where applicable, oversee external vendor/contractor relationships.</li><li>Feedback on any Regulatory Intelligence to International Regulatory Affairs</li></ul><p></p><p><b>Knowledge and Skills</b></p><ul><li>Regulatory expertise in national, MRP, centralized and biotechnology products, medical devices</li><li>Interactions with regulatory authorities</li><li>Working with policies, procedures and SOPs</li><li>Knowledge of national legislation and regulations relating to medicinal products</li><li>Understanding of the registration procedures in Europe and US for MAA, variations, extensions and renewals</li><li>Understanding of drug development</li><li>Experience managing regulatory processes</li><li>Scientific / Technical Excellence</li><li>Supervisory Skills</li><li>Communication Skills: Oral and Written</li><li>Team Work</li><li>Negotiation Skills</li><li>Ability to anticipate and prevent potential issues</li></ul><p></p><p><b>Basic Qualifications</b></p><ul><li>Doctorate degree</li></ul><p>OR</p><ul><li>Master’s degree and 3 years of directly related experience</li></ul><p>OR</p><ul><li>Bachelor’s degree and 5 years of directly related experience</li></ul><p>OR</p><ul><li>Associate’s degree and 10 years of directly related experience</li></ul><p></p><p>Preferred Qualifications:</p><ul><li>Experience in MNCs,</li><li>Experience in biologics</li><li>Experience in medical devices registration field</li><li>Multi-lingual</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.