USRA-GDP Associate/Senior Associate Contractor

This Regulatory Affairs CONTRACTOR  will assist the department with completing regulatory correspondence and submissions; assemble IND and NDA submissions; perform Quality Control reviews of regulatory submissions; and support regulatory activities pertaining to clinical study teams.

RESPONSIBILITIES

• Complete cover letters, FDA Form 1571, and other documentation for submission to FDA as needed.
• Coordinate between regulatory affairs and the regulatory operations group.
• Perform Quality Control reviews of regulatory submissions.
• Assist with the creation and logging meeting minutes.
• Assist with study start up and maintenance activities relevant to regulatory affairs, as needed.
• Assist with project management activities for large regulatory submissions.
• Assist with Trial Master File activities.
• Support larger submissions, such as INDs and NDAs, including organizing the submission review process, preparing sections, reviewing for completeness, accuracy, and appropriateness, and formatting for submission.
• Offer guidance to project teams with regard to regulatory issues.

Other duties could include:

•  With manager’s supervision, interpret and advise regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization to maximize the business benefit and maintain regulatory compliance.
• Establish contact with the FDA as required to support developmental programs.
• Ensure necessary clinical trial information is posted on clinicaltrials.gov, and that all listings are updated appropriately.

REQUIREMENTS

• Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry) preferred.
• Minimum of 2 years of Pharmaceutical industry experience in Clinical Development Operations or Regulatory Affairs preferred.
• Working knowledge and experience in regulatory submissions and product life cycle management.
• Knowledge of drug regulations and guidance with ability to apply to regulatory issues and requirements.
• Ability to coordinate and monitor activities on multiple projects.
• Ability to self-direct workload, including reprioritizing and delivery under tight timelines.
• Detail-oriented team player capable of multitasking and prioritizing.
• Adaptable to changing priorities.
• Proficient in the use of common Microsoft software programs.
• 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.
• Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.

DISCLAIMER

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 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.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.