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.
Provide regulatory strategy and tactical support for assigned projects.
Contribute to developing global / regional regulatory strategies for multiple clinical development projects at all stages (Pre-IND through NDA submission and approval).
Support and perform with limited oversight larger submissions, such as IND applications and NDAs, including organizing the submission development and review process and timeline, preparing sections, reviewing for completeness, accuracy, and appropriateness.
Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed.
Interpret and advise regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance.
Establish contact with the FDA as required to support developmental programs.
Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
Ensure necessary clinical trial information is posted on clinicaltrials.gov, and that all listings are updated appropriately.
Be the primary contact for clinical teams for regulatory needs.
Contribute to process improvement initiatives that generate sustainable, long-term results which drive efficiency, accuracy, and innovation.
Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry). Master’s degree in Science related field strongly preferred.
Minimum of 6 years of Pharmaceutical industry experience with at least 4 of those years in Clinical Development Operations and Regulatory positions.
Working knowledge and experience in regulatory submissions and product life cycle management.
Broad range of experience to include Pre-IND and Phase I clinical development through NDA filing is sought (though not necessarily with same compound).
Knowledge of drug regulations and guidances with ability to apply them to complex regulatory issues and requirements.
Ability to simultaneously plan, coordinate and lead activities on multiple projects.
Ability to self-direct workload, including reprioritizing and delivery under tight timelines.
Excellent written and oral communication skills.
Detail-oriented team player capable of multitasking and prioritizing.
Demonstrate critical thinking efforts.
Exposure to due diligence responsibilities is preferred.
Adapt to new information, changing conditions, or unexpected obstacles.
Proficient in the use of common Microsoft software programs. Exposure to EDMS utilized in document preparation and submissions is preferred.
Experience interacting with Health Authorities.
Experience developing eCTD-compliant documents.
Ability to analyze and communicate scientific information from a broad range of disciplines.
Excellent writing, editing, verbal, and interpersonal communication skills, and strong attention to detail.
Familiarity with CTD, ICH, GCP, and other standards.
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
Telecommuting is allowed.
Internal Number: ASSOC01236
About Shionogi Inc.
Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a 140-year-old global pharmaceutical company with headquarters in Osaka, Japan. In the U.S., Shionogi Inc. leverages our science-based heritage to develop and commercialize pharmaceutical products to treat unmet medical needs in our core areas of infectious diseases and pain, as well as other areas of high medical need, including chronic liver disease.