Associate Director - Global Development Projects
Company: Regulatory Affairs Professionals Society
Location: Florham Park
Posted on: February 25, 2021
The site navigation utilizes arrow, enter, escape, and space bar
key commands. Left and right arrows move across top level links and
expand / close menus in sub levels. Up and Down arrows will open
main level menus and toggle through sub tier links. Enter and space
open menus and escape closes them as well. Tab will move on to the
next part of the site rather than go through menu items. Associate
Director - Global Development Projects - US Regulatory Affairs
Shionogi Inc. Application Attachments: Please include your resume
and up to two additional documents. Add File Pharmaceuticals,
Quality/Risk Management, US Regulatory Affairs Preferred Education:
4 Year Degree
The--Associate Director - Global Development Projects--will work
with senior members of the--US Regulatory Affairs--staff to develop
Regulatory 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, you
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
- 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. NOTES: Telecommuting is
Internal Number: ASSOC01236 About Shionogi Inc. Shionogi Inc. is
the U.S. subsidiary of Shionogi & Co., Ltd., a 140-year-old global
pharmaceutical company with headquarters in Osaka, Japan. In the
U.S., Shionogi Inc. leverages our science-based heritage to develop
and commercialize pharmaceutical products to treat unmet medical
needs in our core areas of infectious diseases and pain, as well as
other areas of high medical need, including chronic liver disease.
Regulatory Affairs Professionals Society (RAPS)
5635 Fishers Lane, Suite 400
Rockville, Maryland 20852
Keywords: Regulatory Affairs Professionals Society, New York , Associate Director - Global Development Projects, Executive , Florham Park, New York
Didn't find what you're looking for? Search again!