Applied Biosystems
Location: Silicon
Valley/Peninsula, California-Silicon Valley/Peninsula 94404
Posted on: 8:50 AM,
Wednesday, September 24, 2008
Position type: Full time
Job Code: 08-21835
Required education:
Area(s)
of expertise desired: Quality
Assurance
Description
Job Description:
·
Manage worldwide Regulatory activities for Food Safety from both a
strategic and operational perspective. In this capacity
he/she will develop regulatory strategies and execute accordingly to ensure
compliance with worldwide regulatory requirements as they pertain to medical
and research use only products.
·
Effectively
liaise, negotiate and partner with the regulatory bodies (e.g., USDA); manage and
coordinate the preparation of all regulatory documents and provide regulatory
support across all global projects, securing the cooperation of others (team
members); meet aggressive deadlines to ensure that regulatory agencies receive
timely and quality information, leading to successful results.
Job Responsibilities:
·
Provide
worldwide regulatory strategy and manage execution of that strategy.
·
Manage and
oversee the preparation, review and submission of regulatory documents, reports
and correspondences.
·
Provide
regulatory guidance with regard to the preparation, review and approval of
labeling and promotional materials for branded products.
·
Participate
in global product team meetings (development and marketed products); provide
regulatory support and guidance and manage day-to-day regulatory activities.
o
Take a
prospective view and determine what needs to be accomplished; build
relationships to implement necessary initiatives.
o
Provide
guidance and ensure that future product development activities are completed
according to defined requirements.
·
Collaborate
with all disciplines within the organization to obtain and/or provide
information/data for regulatory filings.
o
Offer
critical information to project/product development teams so that they
construct plans and develop products that meet or exceed defined requirements.
·
Influence
and evaluate current regulations.
o
Fully
understand the present regulatory requirements related to current and potential
new products.
o
Evaluate
the effectiveness of these regulations and understand how they are evolving. Anticipate potential modifications necessary to
support this rapidly changing area of technology.
o
Influence
the direction of future regulations to support a least-burdensome and safe path
for bringing new technologies to market.
·
Create
strong relationships with partners and key customers to develop and execute
regulatory plans in support of mutual goals and objectives.
o
Work
closely with business partners to educate both internal staff and regulatory
agencies. Help them fully understand the impact and implications of utilizing
these novel products.
·
Provide
proactive regulatory intelligence in areas of a competitive nature and also
keep abreast of changes in regulations and requirements (e.g., USDA, AOAC,
Qualifications:
·
B.S.
degree in science or health-related discipline with a minimum of 7 years
regulatory experience in the health care industry in the areas of biologics,
diagnostics or genomics.
·
In-depth knowledge of the regulatory approval process
(focus on Food Safety); personal experience in working directly with regulatory
agencies; received approval of regulatory packages.
·
Strong functional experience in establishing regulatory
processes with previous success in working on cross-functional project teams.
Ideal Profile:
·
An innovative regulatory professional who thinks beyond
current boundaries and develops solutions which reflect out of the box thinking. Someone who questions existing practices
and initiates new processes by working in partnership with regulatory
authorities.
·
A regulatory professional who is action oriented.
An individual committed to meeting USDA and other regulations and at the
same time to moving projects forward expeditiously.
·
A sound regulatory professional who is credible and can act
as a facilitator and problem solver when working with internal colleagues and
with external regulatory agencies. Someone who
understands specifically what is needed and does not impose overly restrictive
practices.
·
An individual who integrates scientific and regulatory knowledge, understands DNA probes, tests and systems and
comprehends their intended biological uses.
·
A strong communicator with excellent verbal and written
communication skills.
·
An energetic individual who is able to make sound
recommendations which accelerate the regulatory approval process.
A passionate driver who consistently seeks efficiency.
·
A business partner who can ensure that issues are surfaced,
problems are solved, and sound recommendations are made to meet agency
requirements.
·
A credible individual who is skilled in human dynamics, is a good
listener, and is able to influence peers, subordinates and superiors in various
disciplines.
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