Valley/Peninsula, California-Silicon Valley/Peninsula 94404
Posted on: 8:50 AM, Wednesday, September 24, 2008
Position type: Full time
Job Code: 08-21835
Area(s) of expertise desired: Quality Assurance
· 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.
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.
· 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.
proactive regulatory intelligence in areas of a competitive nature and also
keep abreast of changes in regulations and requirements (e.g., USDA, AOAC,
· 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.
· 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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