APAC Regulatory Affairs Manager

<p style="text-align:left !important">At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Regulatory Affairs Group<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Regulatory Affairs<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Professional<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Koto, Tokyo, Japan, Seoul, Korea, Republic of, Shanghai, China, Singapore, Singapore, Taipei City, Taiwan<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><p>The Regional Regulatory Manger Asia Pacific (AP) is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with the local regulatory affairs departments, AP Compound teams, Global Regulatory Teams and head office based team members (e.g. Regional Strategic Implementation Leader) to define and implement the regional strategy for assigned products. The position is accountable for leading and providing regulatory strategic input for assigned products.</p><p>The position, under the supervision, and supported by a supervisor, is responsible, for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications within the oncology therapeutic area, including the opportunity for placement of clinical trials within the region.</p><p>The position also ensures (either directly or through staff) that product variations, including labeling changes, supplements, amendments, Product License Renewals are effected in the region. Furthermore, this position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business. This support includes J&amp;J global products as well as licenced products (global, regional, local) and regional/local developed products.</p><p>Position will ensure that interactions with local/regional manufacturing sites are managed. Position will also manage interactions with manufacturing sites as required to ensure the availability of propoer standard export packaging components for product registration.</p><p>Position will work with regulatory policy professionals as well as local affiliates to keep track of changes in country regulatory requirements and provide regulatory intelligence to regional management and head office. This support includes J&amp;J global products as well as licenced products (global, regional, local) and regional/local developed products.</p><p>Position, under the supervision, and supported by a supervisor, will participate in the adequate preparation for health authority meetings, and may attend and provide presentations to health authorities, where necessary.</p><div></div><p><b>PRINCIPAL RESPONSIBILITIES for Regional Regulatory Manager, Asia Pacific</b></p><p>Provides direction for the activities related with assigned products. Works with regional management, head office-based team members (e.g. Strategic Execution Leader) and local operating companies to define and implement the regional and local strategy for assigned products.</p><p>Under the supervision, and supported by a supervisor, is responsible for the development of the regional regulatory strategy and ensures the implementation of multi-national /regional regulatory and strategies that optimize development, registration, and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.</p><div></div><p><b>Regulatory Strategy and Expertise</b></p><p>▪ Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.<br />▪ Participates as a standing member of the project related GRT; supports the GRT by providing strategic regional input into compound development, registration and life cycle management.<br />▪ Expedites commercialization of new products, new indications and line extension via participation in the AP Compound teams to provide early regional regulatory inputs to identify barriers and needs to shape global developmental plan.<br />▪ Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals<br />▪ Provides input in post-registration activities, including labeling changes<br />▪ Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.<br />▪ Maintains expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements</p><div></div><p><b>Health Authority, Operating Companies, and Business Partner Interactions</b></p><p>Manages regulatory interactions with local operating companies and regional functions<br />▪ Serves as point of contact with local operating companies<br />▪ Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&amp;D partners.<br />▪ Interacts with local operating companies on individual products/processes<br />▪ Facilitates discussions with local operating companies on regional or global regulatory issues, as required<br />▪ Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assist operating company with these interactions.<br />▪ Acts as the primary contact with multifunctional regional teams such as Asia Pacific Therapeutic Area Strategic Team, regional marketing, Alliance logistics and supply chain and trademark office in US.<br />▪ Leads regulatory activities on AP Compound teams.</p><div></div><p><b>Regulatory Submissions</b></p><p>▪ Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).<br />▪ Ensures maintainenance of generic content plans for submissions in the region, including clinical trials and registration submissions<br />▪ Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance<br />▪ Reviews and provides input to critical submission documents?<br />▪ Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines.<br />▪ Participates in “Rapid Response Teams” to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.<br />▪ Ensures tracking of submission and approval milestones<br />▪ Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions</p><div></div><p><b>Additional Responsibilities</b></p><p>▪ Responsible for the management of regional in-licensed registration submissions, including drafting of the license agreement draft (regulatory aspect) (Review by Regional Head).<br />▪ Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities (including CCDS changes) and milestones<br />▪ Updates HQ regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favorable regulatory environment through networking with Industry Group(s).<br />▪ Provides support to the Head of Regulatory Affairs AP to develop metrics for the region.</p><div></div><p><b>Required Technical Competencies &amp; Knowledge</b></p><p><b>Regulatory Strategy</b></p><p>▪ Understanding of the pharmaceutical industry<br />▪ Knowledge of local laws, regulations and guidances in the region related to full drug life cycle.<br />▪ Understanding of how laws, regulations and guidances apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment.<br />▪ Understanding of and experience in drug development and/or marketed products.<br />▪ Under the supervision, and supported by a supervisor, anticipate and influence regulatory developments in the region and assess business impact<br />▪ Under the supervision, and supported by a supervisor, communicate AP regulatory strategy to global teams and assess impact on global/regional drug development<br />▪ Understanding of the scientific and medical principles applicable to the therapeutic area and specific products.<br />▪ Awareness of pricing and reimbursement issues in AP<br />▪ Understanding of how supply chain decisions impact registrations in AP</p><div></div><p><b>HA and Operating Company Interactions</b></p><p>▪ Knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.<br />▪ Under the supervision, and supported by a supervisor, work with and influence HA actions and outcomes.<br />▪ Project-related knowledge of commercial/medical business needs.<br />▪ Understanding of scientific data (CMC, clinical and non-clinical)</p><div></div><p><b>Regulatory Input into Other Functions</b></p><p>Comprehensive understanding of the needs of regional business partners.</p><div></div><p><b>Submissions</b></p><p>• Knowledge of laws, regulations, and guidances as they apply to submissions in the region.<br />• Knowledge of what is needed for dossier components and submissions, how to obtain regional components and how long it will take to gather it. Understanding of documentation requirements.<br />• Ability to analyze reports to determine whether they meet regulatory requirements, and are consistent with the regional regulatory strategy.</p><div></div><p><b>Labeling</b></p><p>• Knowledge of local labeling requirements.<br />• Under the supervision, and supported by a supervisor, critically review labeling development/labeling revisions and assess impact on relevant countries<br />• Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling.<br />• Under the supervision, and supported by a supervisor, undertake labeling negotiations with health Authorities</p><div></div><p><b>DECISION-MAKING AND PROBLEM-SOLVING:</b></p><p>Operates in a competitive, complex, and rapidly changing environment.</p><p>Must make proposals and negotiate on prioritization and trade-offs on a project level.</p><p>Independence on decision-making regarding regional product strategies with supervisor approval.</p><p>Defines operational priorities and tactics in the region. Resolves conflicts in priorities in consultation with supervisor, regional business partners, and head office-based team members (e.g., Strategic Execution Leader and other internal customers).</p><p>Determines risk-management strategies for projects.</p><p>Makes informed decisions by soliciting input from others where needed.</p><p>Makes complex decisions in situations with multiple, ambiguous objectives and constraints.</p><p>Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these.</p><p><b>WORKING RELATIONSHIPS/INTERFACES</b></p><p><b>Internal: Within regulatory affairs:</b><br />Regional Strategic Implementation Leader: to establish project objectives, strategic execution and ensure knowledge sharing.<br />Local Regulatory staff: as needed by project activities to develop and evaluate drug project strategies and objectives and ensure knowledge sharing to enhance product development and registration activities.<br />Global Regulatory Leaders/Global Regulatory Teams: member of the Global Regulatory Team (GRT) with accountability for AP strategy.</p><p><b>Internal: Other functional areas:</b><br />GRPI, Policy, CMC, etc.<br />Interactions with Commercial, Medical Affairs, GCO, and Regional Teams as needed for projects</p><div></div><p><b>KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS</b></p><p>Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline.<br />Minimum of 8&#43; years of overall experience (5&#43; years relevant pharmaceutical industry and regulatory experience) OR Masters/PharmD and 6&#43; years; PhD and 4&#43; years.<br />• Hands’ on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements, preferably relevant experience in the oncology therapeutic area. Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry &amp; Manufacturing, and /or Registration dossiers)<br />• Demonstrated ability to handle multiple projects.<br />• Demonstrated organizational skills<br />• Ability to communicate to senior level management.<br />• Working knowledge of regulations in the region<br />• Experience in HAs interactions.<br />• Excellent verbal and written communication skills – proficiency in written and oral English and [Mandarin/Asian (Asia) languages is preferred.]<br />• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.<br />• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required<br />• Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.<br />• Proficient use of technology including MS office programs and Internet resources.<br />• Some regional business travel (10 - 15%) is required. Occasional international travel (3-5 x/year) may be required.<br />• Must be able to work flexible hours to accommodate early morning/evening meetings/teleconferences with different time zones.</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Analytical Reasoning, Business Writing, Coaching, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility