Title: Executive Director Regulatory Affairs, Geo Expansion
Location: United States-New Jersey-Madison Site
The major objective for this position is set the strategic direction for
Regulatory activities affecting the geo-expansion. This includes but is not
limited to overseeing the development of all regulatory strategies, preparation
of regulatory applications, labeling, advertising and promotional review, and
life cycle management for the pharmaceutical division. . The primary goal of
this project is to meet the deadlines and yearly goals for regulatory
submissions as established for the pharmaceutical division. It is expected that
the targeted yearly submission numbers are met and/or exceeded.
A critical subtask is to oversee health authority liaison activities for all
global geo-expansion submissions. Work with the local regulatory
representatives to ensure proper activities with the appropriate regulatory
agencies.
The primary team role for the Exec Dir, Regulatory Affairs Geo Expansion is
to act as the face for the geo-expansion team for internal and external
stakeholders. You will set the regulatory direction by proactively developing
new and innovative approaches for pursuing business objectives within
regulatory frameworks. The Exec Dir, Regulatory Affairs Geo Expansion will work
closely with a diverse, cross-functional team consisting of clinical
operations, biostatistics, pharmacovigilance and safety. As part of this team
effort, the person will actively be involved in multiple projects and provide
constant leadership and direction throughout the whole process.
This is your chance to expand your growth opportunities by providing
leadership to a company initiative that will have a very strong impact on the
pharmaceutical business unit. This role while very hands on will be
instrumental in the development and evolution of this Regulatory group. Part of
your development in this role will involve providing continuous strategic
insight for the projects for both in licensing and existing products.
Specific Job
Duties(bulleted list of detailed
job responsibilities in order of importance)
Sets the
regulatory direction by proactively developing new and innovative approavhes
for pursuing business objectives within regulatory framework.
Lead regulatory
geo-expansion staff on a global level and ensure close collaboration with the
regional regulatory representatives throughout the world.
Set direction and
strategy for global health authority meetings regarding Bausch Lomb
Pharmaceutical products
Qualifications(include education, prior knowledge, experience or
special skills required to perform the jobs major duties)
Candidates
must be recognized as a regulatory expert internally and externally with
in-depth knowledge of the global regulatory environment affecting the industry
with a proven track record of taking products through to completion.
They
must also have solid business acumen with the ability to work effectively
across diverse functions and levels within the company and understand the key
interdependencies required to develop and market pharmaceutical products on a
global level.
Must
have 15 years of global regulatory affairs experience. Experience with
Ophthalmics is a plus.
Advanced
degree required (Ph.D, MBA, PharmD, JD, MD)
Managerial
Responsibility
There are currently 11
contractors globally that this person will be managing directly.Job: Regulatory Affairs
