技能/経験

■Minimum Requirements
＞Regulatory Submissions Manager I
Employee will be expected to lead submission activities for one or more trials and work directly with Sponsor(s) and develop all regulatory submission specifications (including process, informed consent, regulatory start-up submissions, and timelines). Expected to establish/negotiate study start-up timelines and ensure milestones are met. Responsible for finalizing all regulatory submission documents, assuring quality, completeness, and compliance with local regulations.
 Bachelor’s degree and at least 4 years of Clinical Operations and/or regulatory start-up experience, or Master's/PhD degree within Life Sciences and at least 3 years of Clinical Operations and/or regulatory submissions/start-up experience;
 Possess thorough understanding of regulatory submissions activities;
 Excellent communication and problem solving skills;
 Demonstrated ability to develop, organize, prioritize and manage multiple tasks with varying priority levels;
 Successful experience as primary contact with Sponsor and internal project team; and
 Knowledge of pharmaceutical industry, International Conference on Harmonization guidelines, and FDA or applicable local regulations.

＞Regulatory Submissions Manager II
Employee will lead study start-up activities for multiple moderate to large projects. Responsible for management of projects with minimal supervision. May be responsible for direct supervision of Regulatory Submissions Coordinators and Clinical Trial Assistants, including providing feedback for performance evaluation and competency of team members and skill/career development. Employee is experienced enough to present role of Regulatory Submissions at conferences, external non-project meetings, and bid defense meetings.
 Bachelor's degree and 2 years of regulatory submissions/start-up management experience, or Master's degree within Life Sciences and at least 1 year of regulatory submissions/start-up experience;
 Excellent presentation and facilitation skills; and
 Demonstrated ability to effectively supervise and develop personnel.

＞Regulatory Submissions Manager III
The employee is experienced enough to propose and develop new strategies and processes for the Regulatory Submissions department. May have direct supervisory responsibility of more junior Regulatory Submissions Managers.
 Bachelor's degree and 4 years of regulatory submissions/start-up management experience, or Master's/PhD degree within Life Sciences and at least 3 years of regulatory submissions/start-up experience;
 Demonstrated leadership skills and ability to train and develop more junior department personnel;
 Exhibits strong problem-solving skills; and
 Demonstrated ability to manage conflicts and resolve problems effectively.

＞Senior Regulatory Submissions Manager
Independently functioning individual with management experience and strong interpersonal skills. Employee will provide budget estimates for bid proposals and presents proposals to Sponsors. Responsible for allocation of resources and development of Regulatory Submissions Coordinators, Regulatory Submissions Managers, and Clinical Trial Assistants. Employee will lead and coordinate departmental initiatives related to process building/improvement and integration of new processes for applicable region. Responsible for maintaining effective communication with Director, Regulatory Submissions so he/she is aware at all times of critical issues confronting projects and action plans that have been put in place to address those critical issues.
 Bachelor's degree and 6 years of regulatory submissions/start-up management experience, or Master's/PhD degree within Life Sciences and at least 5 years of Regulatory Submissions experience;
 Demonstrated ability to organize, instruct and supervise a team in the completion of multiple tasks/projects; and
 Demonstrated ability to effectively interact face-to-face with Sponsors and represent company in outside settings.

■Mental Demands
The degree and type of independent judgment and mental effort needed to solve problems associated with the job.
The employee is expected to efficiently and accurately manage one or more projects. Initiative and insight into the research process are required to anticipate potential problems before they arise. Independent decision making is required.

■Supervision Exercised
Number of employees directly and indirectly, type of work performed, type of supervision exercised, and identification of functional responsibility.
Direct supervisory responsibilities for Regulatory Submissions Coordinators and Clinical Trial Assistants (Regulatory Submissions Manager II and above) and Regulatory Submissions Managers (Regulatory Submissions Manager III and above).