The Senior Associate, US Regulatory Affairs for Global Development Projects (GDP) will participate in learning to develop strategies for projects leading toward filing of INDs and NDAs.
Will assist the department with completing regulatory correspondence; performing Quality Control reviews; and implementing strategies focused on pending INDs and NDAs. As a global team member, the Sr. Associate will focus on clinical trials, due diligence efforts and performance of Quality Control reviews of regulatory submissions.
Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed.
Support INDs and NDAs, including organizing the review process, preparing sections, reviewing for completeness, accuracy, and appropriateness.
With managers supervision, interpret and advise regarding regulations, key issues, risks and any other critical topics interacting with interdisciplinary teams and other groups within and outside the organization to maximize the business benefit and maintain regulatory compliance.
Perform Quality Control reviews of regulatory submissions.
Offer guidance to project teams regarding regulatory issues.
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.
Assist with creating and logging meeting minutes and study-start-up as needed.
Bachelors degree in Science (e.g. Chemistry, Pharmacy, Biochemistry).
Minimum of 3 years of Pharmaceutical industry experience in Clinical Development Operations or Regulatory Affairs.
Working knowledge and experience with product life cycle management and prior experience working with clinical operations teams.
Prior experience working with IND and NDA submissions is a plus.
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.
Experience interacting with Health and Regulatory Authorities.
Experience developing eCTD-compliant documents.
Ability to analyze and communicate scientific information from a broad range of disciplines.
Excellent written and oral communication skills - writing, editing, verbal.
Solid interpersonal 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.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
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 responsibilitiesmay 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity