The Senior Manager will work with senior members of the US Regulatory Affairs staff to develop 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, the Sr. Manager 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 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.
Bachelors degree in Science (e.g. Chemistry, Pharmacy, Biochemistry). Masters degree in Science related field strongly preferred.
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 with ability to offer guidance and 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 and experience utilizing them through interaction with the FDA.
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.
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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity