Director, Regulatory Affairs
Company: Brightleaf Group
Location: Irvine
Posted on: April 9, 2021
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Job Description:
Director, Regulatory Affairs--(Science & Biotech) Irvine, CA
92614
Recruited by: Sheryl Horowitz - Recruiter - F-O-R-T-U-N-E Personnel
Consultants, Inc. See all my Jobs
OR Submit your information and resume instantly with Monster! Job
Description Overall Purpose:
Reporting into the VP of Regulatory Affairs, the Director of
Regulatory Affairs and Pharmacovigilance is responsible for the
creation, revision and review of various documents associated with
clinical research. The documents may be submitted to Health
Authorities worldwide to support clinical development and
registration of our client's ophthalmic drug candidates. This
position is also responsible for overseeing post marketing
pharmacovigilance and promotional activities. Furthermore, the
incumbent will demonstrate strong agility to change, and leadership
to mentor, coach and inspire others in manner that will positively
contribute to the successful execution of Regulatory and
Pharmacovigilance strategy.
Essential Duties and Responsibilities:
Primary Responsibilities
--- Perform medical/regulatory writing activities that support the
preparation of regulatory and clinical documents required to
support global drug development and registration activities (N.A.,
EU and Japan)
--- Serve as regulatory affairs representative on assigned product
teams and closely collaborate with personnel from clinical and
scientific departments
--- Assist in writing, editing and reviewing of diverse regulatory
and clinical documents including clinical study reports (CSRs),
study protocols, investigator brochures, clinical data summaries,
and other medical/regulatory documents, including regulatory
summary documents (e.g., ISE/ISS reports) and clinical labeling
sections
--- Develop, implement and manage content templates and
documentation format required for standardization of regulatory and
clinical documentation to support the company's development and
registration activities
--- Coordinate and conduct interdepartmental review and sign-off
document deliverables according to procedures
--- Oversee post-marketing pharmacovigilance system and procedures
and preparation and submission of the post-marketing
pharmacovigilance reports as required
--- Oversees IND clinical amendments, including expedited safety
reporting
--- Oversees the pre- and post-marketing promotional activities
--- Reviews safety management plans for clinical trials
--- Works on Advisory Committee presentations
--- Handles various types of regulatory submissions with minimal
oversight
Qualification Requirements:
Education & Experience
Bachelors or advanced degree (MS, PhD or MD) in Life
Sciences/Health-Related Sciences with at least 5-10 years of
regulatory affairs & post-marketing pharmacovigilance experience in
a pharmaceutical or biotechnology company, preferably in the
ophthalmic therapeutic area. Experience with review of
post-marketing promotional materials and filing requirements, a
plus
Knowledge & Abilities
--- Knowledge of global regulatory publication guidelines (FDA,
EMA, ICH, etc.) and best practices
--- Proficient in pertinent software, such as Microsoft Office
Suite and bibliographic software
--- Knowledgeable in international dossier preparation (e.g.,
IND/CTA/NDA/MAA/NDS), including electronic document submissions
(i.e., etc.)
--- Excellent written/oral communication skills
--- Ability to lead through ambiguity, inspire and motivate
team
--- Agile in ability to identify opportunities for and lead through
change
--- Clear, transparent, and inspiring communicator, able to achieve
through others
--- Demonstrate leadership behaviors that inspire others
--- Coach and mentor to team members
--- Ability to understand and interpret data/information and its
practical application
Postings is a Trademark of Mingle, LLC. Copyright 2015 Mingle, LLC.
All rights reserved.
Keywords: Brightleaf Group, Irvine , Director, Regulatory Affairs, Executive , Irvine, California
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