Job Information
System One US Regulatory Affairs– GDP, RA, Associate in Florham Park, New Jersey
Position: CONTRACTOR -- US Regulatory Affairs– GDP, RA, Associate
Location: Remote (East or Central Time Zone)
Contract: 12mns
Pay Rate: 25/hr - 35/hr
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.
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.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.