Director, Regulatory Affairs (Remote
Company: IQVIA Argentina
Location: Durham
Posted on: February 24, 2021
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Job Description:
Primary Location: Durham, North Carolina, United States
Additonal Locations: Cambridge, MA, USA; Overland Park, KS, USA;
Parsippany, NJ, USA; San Diego, CA, USA Full time R1185729 Date
Posted: 02/18/2021 Details:
---Manage a team of Regulatory Affairs professionals. ---Provide
support for key regulatory activities pertaining to a
project/product.
--- Interact with internal project related teams for all parts of
RA aspects of a given project on clinical RA strategy or procedural
aspects.
--- Participate in project/product-related discussions and provide
strategic, scientific and RA input, for all parts of RA aspects of
given project on clinical or procedural aspects.
--- Provide input into the asset specific regulatory strategy on a
global scale.
--- Coordinate (for one or more specific sections) the
determination of key messages for product/portfolio specific
regulatory documents to be submitted to Authorities
--- For cross-product sections or stand-alone documents work with
the functional regulatory groups to ensure content is aligned with
targeted overall profile of the product.
--- Responsible for the delivery of high quality project/product
specific regulatory documents to be submitted to Authorities and
ensure that those documents meet regulatory requirements.
--- Facilitate and deliver the regulatory strategy to support the
lifecycle of the asset; contribute for clinical and procedural and
accountable for one or several of the RA aspects.
--- Act as the point of contact for Regulatory Agencies for assets
; Plan and lead activities associated with FDA meetings pertaining
to a project/product
--- Be aware of changes in regulatory guidelines and their impact
on regulatory strategy for the particular asset(s).
--- Develop and motivate collaborators (within RA team and in
multidisciplinary teams) to achieve quality output, accountability
and recognition across the organization and towards the regulatory
authorities. Qualifications:--
8+ years significant experience in regulatory affairs, or
appropriate relevant experience.
Ph.D Pharmacy, Chemistry, Biology or Science Degree
--- Experience in providing strategic advice on integrated
regulatory development plans with a focus on CMC, and problem
solving in cross-functional teams in drug/vaccine development
---Ability to coordinate and execute regulatory strategy for a
given project/product.
---Ability to assess and determine regulatory strategy for
development and life cycle management programs.
---Strategic thinker - ability to provide input into regulatory
strategy and evaluate potential impact on overall project/product
strategy.
---Ability to identify and escalate issues to and to propose
mitigation strategies, maximize opportunities, with proven ability
to develop collaborative relationships and have high impact and
influence
---Proven influencing skills.
---Ability to collaborate with other departments and teams in the
delivery of outputs in a timely manner
---Ability to resolve problems through resourceful use of
information and contacts.
---Enterprise thinking - needs to assess the potential impact on
RA, including how RA may facilitate in achieving the overall
goal.
---Quality mindset
---Fluent in English, with excellent writing skills.
---Able to input into the Company's regulatory positioning, and
write /critically review key documents targeting internal or
external key audiences.
---In collaboration with the function and regions, ensure rigorous
scientific content/quality/compliance of documents intended for
regulatory submissions. At IQVIA, we believe in pushing the
boundaries of human science and data science to make the biggest
impact possible - to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research
services we provide to the life sciences industry are made possible
by our 67,000+ employees around the world who apply their insight,
curiosity and intellectual courage every step of the way. Learn
more at jobs.iqvia.com .
IQVIA is an EEO Employer - Minorities/Females/Protected
Veterans/Disabled IQVIA, Inc. provides reasonable accommodations
for applicants with disabilities. Applicants who require reasonable
accommodation to submit an application for employment or otherwise
participate in the application process should contact IQVIA's
Talent Acquisition team at workday_recruiting@iqvia.com to arrange
for such an accommodation.
Keywords: IQVIA Argentina, Durham , Director, Regulatory Affairs (Remote, Executive , Durham, North Carolina
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