Sr. Manager US Regulatory Affairs - Global Development Proje
Company: Shionogi Inc
Location: Florham Park
Posted on: February 25, 2021
Sr. Manager US Regulatory Affairs - Global Development Projects
Florham Park, NJ, USA
Description The Senior Manager US Regulatory Affairs for Global
Development Projects will participate as a global team member
focused on development projects and due diligence efforts. Diverse
duties will include, but are not limited to, participation 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
submissions; and performance of Quality Control reviews of
regulatory submissions. Will work with the senior staff to develop
Regulatory Strategy and Process Improvement initiatives.
- Provide regulatory strategy and tactical support for assigned
- 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
- 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
- Manage regulatory timelines, interactions, and
regulatory-specific study activities with CRO organizations as
- Ensure necessary clinical trial information is posted on
clinicaltrials.gov, and that all listings are updated
- Be the primary contact for clinical teams for regulatory
- Contribute to process improvement initiatives that generate
sustainable, long-term results which drive efficiency, accuracy,
and innovation. REQUIREMENTS
- Bachelor's degree in Science (e.g. Chemistry, Pharmacy,
Biochemistry). Master's degree in Science related field strongly
- Minimum of 6 years of Pharmaceutical industry experience with
at least 4 of those years in Clinical Development Operations and
- 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
- Demonstrate critical thinking efforts.
- Exposure to due diligence responsibilities is preferred.
- Adapt to new information, changing conditions, or unexpected
- Proficient in the use of common Microsoft software programs.
Exposure to EDMS utilized in document preparation and submissions
- Experience interacting with Health Authorities.
- 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. To be considered for this
position, you must apply and meet the requirements of this
opportunity. We look forward to reviewing your resume &
qualifications. 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.-- EEO-- 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 contractor's legal duty to
furnish information. 41 CFR 60-1.35(c)
Keywords: Shionogi Inc, New York , Sr. Manager US Regulatory Affairs - Global Development Proje, Executive , Florham Park, New York
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