Regulatory
Manager - Food Safety: Applied Biosystems
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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.
To apply for the position, click here
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