Associate Director - Global Development Projects – US Regulatory Affairs (Project Management)
The Associate Director - Global Development Projects will work with senior members of the US Regulatory Affairs staff to develop Regulatory Strategy and Process Improvement initiatives. Will participate in development program planning and execution, study teams, and study-related activities; preparation of components of IND and NDA submissions including regulatory correspondence, and completion of submission documents.
As a global team member, you will focus on development projects, due diligence efforts and performance of Quality Control reviews of regulatory submissions.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.Regulatory