Regulatory Affairs Manager

<h2><b>Career Category</b></h2>Regulatory<h2></h2><h2><b>Job Description</b></h2><p><b><span>Group Purpose</span></b></p><h2><span>Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. </span><span> </span></h2><p></p><p><b><span>Job Summary</span></b></p><h2>The Local Regulatory Representative (Manager) is assigned to one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.</h2><ul><li>Assist in aligning local regulatory requirements with Amgen’s corporate standards.</li><li>Provide national/regional (as applicable) input to and execute regulatory strategies.</li><li>Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.</li><li>Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.</li><li>Act as the point of contact with regulatory agencies.</li><li>Develop, communicate and coordinate the regulatory strategy for pipeline</li><li>Plan and manage clinical trial applications through CRO and liaise/coordinate CTA response to queries between CRO and Amgen.</li><li>Manage CRO work invoice and participate in global network.</li><li>Work as a primary point of contact and oversight for Global Regulatory Affairs &amp; Safety (GRAAS) between the in-country Functional Service Provider (FSP) and Amgen, ensuring that the FSP delivers per contract as well as the timelines and quality of all regulatory and safety filings.</li></ul><p></p><p><b><span>Key Activities</span></b></p><p></p><p><b><span>Strategic and Execution</span></b></p><ul><li>Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.</li><li>With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.</li><li>Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.</li><li>Creates, reviews and approves source text for country labeling, and owns the country artwork based on source text.</li><li>Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).</li><li>Reviews and approves the promotional and non-promotional materials.</li><li>Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.</li><li>Monitors the external regulatory environment to help inform/advise in the regulatory decision making.</li><li>Ensures/supports regulatory product compliance (e.g. RIM, PMCs, pediatric and other agency commitments, Renewal).</li></ul><p></p><p><b>HEALTH AUTHORITY INTERACTIONS</b></p><ul><li>Acts as the point of contact with regulatory agencies in fulfilling local obligations.</li><li>Participates/contributes to local agency interactions and their preparation.</li></ul><p></p><p><b>COMMUNICATION AND COLLABORATION</b></p><ul><li>Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.</li><li>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.</li><li>Partners with International Regulatory Leads (IRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li><li>Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).</li><li>Establishes regular contacts and interactions with Distributors (if applicable).</li></ul><p></p><p><b>COUNTRY SPECIFIC ACTIVITIES</b></p><ul><li>Assists locally in Healthcare Compliance activities where applicable.</li><li>Participates in local regulatory process improvements, initiatives and training.</li><li>Oversees external vendor/contractor relationships where applicable.</li></ul><p></p><p><b><span>Knowledge and Skills</span></b><br /> </p><p><b>Scientific and Technical</b></p><ul><li>Knowledge of Regulatory principles.</li><li>Working with policies, procedures and SOP’s.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>General knowledge of national legislation and regulations relating to medicinal products.</li><li>General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.</li><li>Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.</li><li>Understanding of drug development.</li></ul><p><br /><b>Others</b></p><ul><li>Demonstrate strong team work ability.</li><li>Good communication skills - both oral and written.</li><li>Good negotiation and Influencing skills.</li><li>Ability to understand and communicate scientific/clinical information.</li><li>Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.</li><li>Cultural awareness and sensitivity to achieve results across both regional, country and International borders.<br /> </li></ul><p><b><span>Education &amp; Experience </span></b></p><p><b><span>Basic</span></b></p><ul><li>Doctorate or Master’s degree (scientific area) and 3 years of directly related experience OR <span>Bachelor’s degree (scientific area) and 5 years of directly related experience</span></li></ul><p></p><p><b><span>Preferred</span></b></p><ul><li>Degree and in-depth regulatory experience and/or related to the country(ies).</li><li>Depth knowledge of country(ies) legislation and regulations relating to medicinal products.</li><li>Experience in plan/submit/approval of New drug application</li><li>Experience in clinical trial application and negotiation with MFDS.</li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.