Director, Regulatory Affairs

Title : Director, Regulatory Affairs

Location : Tokyo, Japan

The Director, Regulatory Affairs provides Regulatory expertise in strategic drug development across multiple areas. As a Director, Regulatory Affairs, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. You are responsibilities are as follows :

• Demonstrates and actively promotes an open and honest working environment to encourage close teamwork and foster knowledge transfer

• Travel (up to 25% dependent upon business needs) domestic and/or international.

• Proactively communicates objectives and results with clients, leadership team and all functional partners

• Undertakes all required tasks requested to meet departmental and project goals and manage and lead various departmental initiatives as required

• Represent ICON Regulatory Affairs at conferences, committees, webinars and other suitable opportunities

• Performs other duties and tasks as are allocated at the reasonable discretion of the Company

Subject Matter Expert :

• Applies scientific principles and maximize compliance to all aspects of regulatory activities undertaking

• Oversee preparation and review of scientific and regulatory documents and communication to Regulatory Authorities, in collaboration with internal and external functional experts

• Oversee preparation of/review/ or write core regulatory submissions to support CTA, IND, MAA, NDA or equivalents

• In collaborations with functional experts, advise on regulatory aspects of protocols and clinical trials.

• Development and implementation of strategies and regulatory submissions for PIP, OD, SME, applications, post-licensing activities as applicable

• Function as primary liaison with regulatory agencies for designated projects and designated clients

• Lead and take oversight on the regulatory intelligence function

• Oversee and lead regulatory input for regulatory agency meetings

• Perform high-level review and sign-off authorization of regulatory submissions as required

• Develop and maintain an in-depth current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary

• Advise senior management of key regulatory developments and their implications to ICON and to our clients

Client Development

• Conceptualizes and drafts, or leads, a complete proposal based on a client idea or RFP

• Be aware of project contracts and terms, be able to review them critically and initiate change orders when needed. Manage the financial control of projects (from contract state to invoicing) and be involved in financial processes within the department

• Acts as scientific thought partner with the client and the project team throughout the project

• Initiates and nurtures client relationships and maintains contacts to build reputation and deal flow

• Key account lead for a combination of current and prospective clients

• Independently develops project plans and scientific content in proposals and achieves good conversion rate of submitted and won proposals

• Represents Service Line at internal and external meetings and strategy review presentations/overviews

• Maintains positive client contact, serves as escalation path for unresolved issues as necessary, and initiates client dialogue and updates on project progress

• Regularly contributes to industry thought leadership

Project and Risk Management

• Takes ownership of final budget, deliverable and project timeline and to deliver the work on time, in a profitable manner

• Efficiently balance resourcing and financial results to meet the clients' needs and departmental goals, including outsourcing strategies

• Organizes and monitors workloads in line with budget and time to ensure project efficiency and quality of insight

• Anticipates key project risks. Proactively develops and executes mitigating strategies effectively as required

Operational

• If a People Leader, responsible for the human resource management activities including maintenance of proper staffing levels, resource optimization, attainment of individual and team goals, employee relations, mentoring, talent/career development, and rewards/recognition based on achievement of goals

• Delegates and ensures completion of special assignments (e.g. job descriptions, handbook updates, SOP scientific consulting)

• Complies with all relevant SOPs, work programming, time-keeping, iLearns, policies and procedures

Requirements

• In depth proven experience in regulatory affairs or aligned work, in particular to Japan.

• Proven experience in managing a group of regulatory affairs professionals

• Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction in Japan.

• Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail

• Excellent written and communication skills

• Good written and spoken English and native-level Japanese are required

• Bachelor's degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. Master's degree or higher preferred.