Director Of Regulatory Affairs Jobs in Illinois

Job Title: Manager, Regulatory Affairs Company: Location: Chicago, IL Description: Apply here "http://www.jobvite.com/j/?aj=o0uhVfwq&s=craigslist" Manager, Regulatory Affairs Company Overview As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. We are a research-based company, enhancing our R&D pipeline by concentrating our management resources. Takeda's in-house ethical drugs are marketed in around 90 countries worldwide and are recognized as the brand leader in major countries worldwide. Our management philosophy, "Takeda-ism" is the basis of our business as we continue to grow and prosper. Takeda is an energetic company that attracts and retains well-qualified personnel from all over the world. We strive to maximize the capabilities of our work force by creating a corporate climate that is appealing and encouraging to skilled and ambitious individuals. This will entail preparation of a global personnel program that, first and foremost, fairly evaluates and rewards employees for the results they achieve. Job Description We are currently seeking a Manager, Regulatory Affairs to provide guidance and expertise to the global project team. General responsibilities include: identifying regulatory requirements, manage all regulatory activities for lead compounds, mentor junior regulatory personnel, and communicate with the FDA at the Division level. Responsibilities: Provides regulatory guidance and expertise to global project team on the assigned project(s) of responsibility. Identifies regulatory requirements and data reporting deadlines to ensure registration and approval of drug products. Plans/manage/execute all regulatory activities for lead compound(s) in development and supports regulatory activities for assigned marketed product(s) of responsibility. Mentors and provides guidance to more junior regulatory personnel. Provides regulatory support in FDA meeting preparation. Interacts with the Project Management Staff at the FDA Divisional level. May interacts with other levels of FDA within the Division(s) of responsibility Independently provides regulatory advice and guidance to the development team on most development issues. Plans, executes and manages regulatory submission for key compounds in various phases of development, including post-approval life cycle management activities for marketed products. Ensure regulatory compliance of marketed products. Manages FDA meeting preparations. Acts as the lead regulatory representative at some FDA meetings. Communicates with the FDA at the Division level and state regulatory agencies as required. Provides input into the product development strategy and executes implementation. Manages the preparation and submission of major regulatory submissions. Provides input into regulatory risks assessment and makes recommendations relative to the overall strategy. Manages others drug development regulatory professionals. Requirements BS/BA Degree and 4+ years of pharmaceutical industry experience to include 2+ years of increased regulatory responsibility. Knowledge of FDA regulations. Understanding of scientific principles and regulatory/quality systems relevant to drug development Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings. Travel Requirements Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 20% travel. Integrity in All That We Do! Takeda's basic human resource principal is to "develop a high-performance, results-oriented culture within our organization with motivated employees who take pride in and find a sense of accomplishment from their work." To that end, we provide a comprehensive compensation and benefits package designed to promote the health and happiness of our valued employees and their families! Apply today and start a quality career with Takeda!

Job Title: Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA Company: CyberCoders Location: Chicago, IL Description: Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA .body .body h4 .body .section tr.oddRow a, a:link, a:visited Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA near New York City, NY This job is open as of 3/1/2010. Apply Now! Not a fit for this job? Search other Associate Director Regulatory Affairs jobs! Are you an employer? Visit us for more info! Email this job to a friend - $1000 Location New York City, NY; Chicago, IL Salary $130,000 - $175,000 Education PhD Category Strategy - Planning Experience Required At least 2 Years Short Description Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA Required Skills Regulatory, Manager RA, Associate Director Drug Regulatory Affairs, Pharmaceutical, Clinical, IND/NDA, Regulatory Strategy, biotech, global, life cycle teams Recruiter Erin Beagle Date Updated 3/1/2010 Skills Required Regulatory, Manager RA, Associate Director Drug Regulatory Affairs, Pharmaceutical, Clinical, IND/NDA, Regulatory Strategy, biotech, global, life cycle teams Job Description Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDAIf you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and IND/NDA experience, please read on!A top, multi-national pharmaceutical company based in Northern New Jersey, is looking for an Associate Director of Drug Regulatory Affairs/ Regulatory Strategist to join their team! If you aren't local to the NYC/North Jersey Metropolitan area, but posses the requisite experience, my client will provide a comprehensive relocation package to get you there!What you need for this position:-An Advanced degree - PhD or PharmD, is strongly preferred!-At least 5+ years of experience developing regulatory strategies in the pharma industry-IND/NDA writing/filing experience-A background in Clinical development is a plus!- Focus in Clinical Regulatory Strategy - not CMCWhat you'll be doing:-Developing regulatory strategy for a global pharmaceutical company-Working hand in hand with the Director of Global Drug REgulatory affairs and with Global drug life cycle teams-Managing and developing strategy for global submissions-Lead a team of regulatory professionals through implementation of your strategies and the submission process, as well as IND/NDAWhat's in it for you:-Extremely competitive salary and bonus structure-Opportunity to work in a global organization making a direct and immediate impact on the regulatory affairs groupSo, if you are you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and and IND/NDA experience, please apply today!Must be authorized to work in the United States on a full-time basis for any employer. Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Not a fit for this position? Click Here to Search Other CyberCoders Jobs! Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, or you may also: Email your resume in Word to: Register to View **Please do NOT change the email subject line in any way. You must keep the JobID: CC HotJobAp : EB-NJRegAD -- in the email subject line for your application to be considered.*** Erin Beagle - Executive Recruiter - CyberCoders Other Jobs

Job Title: Regulatory Affairs Manager Company: The Cambridge Group Ltd. Location: Highland Park, IL Description: Regulatory Affairs ManagerThe Regulatory Affairs Manager will have responsibility for providing regulatory strategy and support for the company’s Regenerative Medicine business. In this position, the candidate will interact with a global team involved with the development and maintenance of our cellular therapy and biosurgery products.  The incumbent will develop and execute regulatory plans for complex projects including new and existing products within the company’s stem cell, surgical sealing and hemostatic product portfolio.  Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.  Ensure project teams and business objectives and deliverables are aligned with regulatory strategy. Monitor applicable regulatory requirements, assure compliance with the company and external standards. Assess impact of new regulations and provide feedback.  Gather regulatory intelligence regarding the global regulatory environment and competitive products.  Develop and document sound regulatory decisions and justifications.  Represent or lead the RA function on assigned cross-functional project teams.  Communicate proactively and report to regulatory authorities.  Maintain appropriate communication within the RA function and other functions primarily at the project team level.  Initiate, manage and maintain operational activities in support of new and existing marketing authorizations.  May provide direct supervision of individuals including mentoring and performance management.  May review promotional material or SOP’s for compliance with local and global regulations.  The successful candidate must have sound basis of regulatory knowledge related to biologic or medical device products (combination product knowledge is an advantage).  Working regulatory knowledge of preclinical and clinical product development, as well as regulatory experience with biologics or medical device manufacturing.  Good scientific knowledge.  Ability to manage multiple complex projects and timelines in a matrix team environment.  Demonstrated interpersonal and collaboration skills, including strong negotiation skills. Strong oral and written communication and presentation skills.  Ability to independently identify compliance risks and escalate when necessary. Ability to lead and coach others.  A minimum of 4 years regulatory experience in RA or related field, including managing people or projects is required. A BS degree or equivalent in related field, but relevant post graduate degree is preferred.Please refer to job code SD7068 when responding to this ad.

Job Title: Regulatory Affairs Manager Company: Abbott Location: Des Plaines, IL Description: Employer Information About Abbott At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. Job At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. Regulatory Affairs Manager Job ID 72572BR Des Plaines, IL PRIMARY JOB FUNCTION: Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control and performs global regulatory impact assessment Provides consultation/advice to regulatory specialist for change control and product development Provides regulatory direction/interpretation on team activities Interprets and applies regulatory understanding to support of products and teams Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. U.S. submissions may include Pre-IDE, IDE, 510(k), PMA and PMA supplements. Handles regulatory activities involved in documentation, labeling, field support Applies regulatory and technical knowledge to a wide variety of complex work assignments Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures. CORE JOB RESPONSIBILITIES: Responsible for implementing and maintaining the effectiveness of the quality system. Executes regulatory requirements in relation to product development, submissions, product maintenance, and project plans Implements Division Regulatory Strategy in specific product-related activities Provides risk benefit analyses on a daily basis for specific product area Basic understanding of laws and regulations related to the division and applies that basic knowledge and interpretation to the solution of issues and to product development and support Analyzes the input of cumulative product changes to current product submissions. Shares knowledge and expertise with others in department and on teams. Provides solutions to wide variety of difficult problems where analysis requires moderate degree of evaluation. Makes presentations to groups division-wide; recommends action or persuades the audience to commit to action; develops formats for reports and presentations. Prepares and aligns impact goals with department goals. Conducts division-wide regulatory training. Interacts and may lead project and division-wide cross-functional teams. Develops positive working relationships with peers in Regulatory Affairs and with project and division-wide cross-functional groups at the business team/management level. Participates in conflict resolution at the cross-functional team level. Makes plans to accomplish multiple activities/projects, establishes priorities to meet multiple demands, optimizes use of resources. Works on developing and improving new planning processes. Develops project timelines, including resource requirements. Implements project plans using resource, budget, and regulatory requirements to meet project goals. Follows GMP guidelines and procedures. Works within all GMP guidelines and procedures. POSITION ACCOUNTABILITY/SCOPE: For all products division-wide, advises and communicates to project, group or venture regarding complex regulatory strategies. Sign-off at team level within delegated parameters; first level approval for change control; may have second level approval authority. Release authority for labeling/sales/ promotional materials. Official correspondence with outside regulatory agencies are guided by management staff. Conducts basic negotiations and conflict resolution on routine product related issues with government agencies. Follows through on submission related activities to secure product approval. Directs own daily activities by utilizing team goals and division regulatory priorities. Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Files submission documents with government agencies with review by supervisory staff as needed.

Job Title: Regulatory Affairs- Manager/Director Company: Abbott Laboratories Location: Abbott Park, IL Description: Regulatory Affairs – Managers / Directors At Abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. Today, 72,000 Abbott employees are doing work that matters. We are currently seeking for talented Regulatory Professionals to join our organization at various sites. Positions include, but are not limited to Manager of Documentation and Labeling, Regulatory Managers, Associate Directors, and Directors. The divisions currently seeking motivated candidates are Abbott Diabetes Care, Abbott Diagnostics, Abbott Molecular, Abbott Vascular, and Abbott Pharmaceuticals. Locations: California, Illinois, Massachusetts, New Jersey Depending upon the position, responsibilities may include: Development and implementation of strategies to insure earliest product introduction into domestic and international markets. Handles/manages regulatory submissions activities and Medical Device Reporting. Insures labeling, advertising and promotional activities meet applicable regulatory requirements. Will interact with regulatory agencies as required Manage and maintain compliant change control system for controlled documents that include product labeling, ensuring that documentation for change packages is approved Depending upon the position within Abbott’s Pharmaceutical division, responsibilities may include: Interacts with FDA on key projects and issues including direct negotiation with review division personnel, and DDMAC reviewers. Direct and manage the preparation and review of regulatory documentation for agency submission. Develop and implement internal and external strategies to proactively take lead to respond to legislation/guidance with impact on Abbott businesses. Draft and/or edit internal process and standards documents relating to publishing and publishing deliverables. Assess and resolve labeling issues taking into account global regulatory requirements Education Requirements: Bachelor’s Degree; advanced degree preferred Depending upon the position, requirements may include: Minimum 5 years of regulatory experience that includes US and/International experience Management/Project Management experience Knowledge and experience working with FDA and ISO regulations Knowledge of regulations and standards affecting IVDs and Biologics. International experience (PAJAME, Latin America, Europe) Interactions with regulatory bodies 510 (k) submissions PMA submissions (which ones-please be specific): Regulatory labeling Regulatory promotions (product marketing, advertising, DDMAC) Medical Device Reporting Previous experience working with a change control system in a regulated industry Familiarity with electronic document control systems preferred. Strong therapeutic background Prior experience working with Preclinical, Clinical, CMC organizations (Abbott’s Pharmaceutical Division) Experience with publishing-related software tools including Documentum, Adobe Acrobat, and MS Word, etc (Abbott’s Pharmaceutical Division) Submissions (NDA, INDA, ANDA, PLA, NADA, BLA) (Abbott’s Pharmaceutical Division) Experience with drug development/product lifecycle (Abbott’s Pharmaceutical Division) Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence. Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference. Through our diverse healthcare businesses, we connect people and potential in ways that no other company can. Discover a world of opportunities at Abbott. EEO Statement: At Abbott, we believe that diversity drives innovation. Innovative thinkers who are passionate about the work they do, Abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.

Job Title: Manager, Regulatory Affairs (03) Company: Global Healthcare Location: Chicago, IL Description: Position:  Global healthcare company is seeking a dynamic, self starting individual to assume ownership of assigned regulatory projects. In this self directed project role the selected individual will be responsible to perform the following functions: Provide global regulatory input for new product development and on-market support of software controlled medical device products including software accessories, interfaces, and associated single use medical devices. In the performance of those duties the individual will execute regulatory plans for those projects including new products and maintenance of licenses/authorizations for existing marketing products. Additionally, he/she will ensure that regulatory submissions and design documentation meet corporate and departmental standards with respect to technical expertise and will resolve any conflicts relating to the design.To be considered for this position you must possess a bachelor’s degree in engineering or in a scientific discipline in addition to 5-7 years directly transferable 510k experience with software driven medical device products for a global market. Proven ability to mentor, lead, and positively influence others in meeting project timelines will be essential for success.

Job Title: Regulatory Affairs Manager Company: Aerotek Scientific Location: Chicago, IL Description: A client of ours has an immediate opening for a Regulatory Affairs Manager in the Northwest Suburbs of Illinois. The Regulatory Affairs Manager is responsible for providing regulatory support and new product development strategies and submissions for drug/device combination products. Major job duties and responsibilities:-Provide regulatory expertise and technical knowledge to fulfill requirements.-Review and approve product labeling and advertising for compliance to applicable regulatory requirements.-Interact directly with regulatory agencies to answer questions and move submissions forward. -Establish and maintain rapport with agency contacts.-Keep apprised of global regulatory requirements and inform product teams of upcoming changes in the regulations.-Provide regulatory advice, review and approval of technical documents including product specifications, clinical protocols, test plans and risk documentation.-Act as core team regulatory lead to represent regulatory affairs on assigned product and project teams and establish regulatory strategies that align with world-wide objectives.-Independently plan and manage regulatory strategies and submissions for complex new product development and change control projects.Job requirements and qualifications:-Bachelor's degree or equivalent experience. -5 years of experience in regulatory affairs including experience directly interacting with project teams. -US submission experience. (IND, IDE, NDA, 510(k), and/or PMA)-Experience managing multiple projects and deadlines.If you are interested in learning more about this opportunity please contact Mary Jo Orbegoso at Register to View or morbegos(AT)aerotek.com.Join Aerotek Scientific LLC(SM), one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.

Job Title: Regulatory Affairs Manager/Specialist - IVD Experience Needed Company: Location: Chicago, IL Description: Regulatory Affairs Manager Grifols has been a leader in the healthcare industry since 1940 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed product designed to improve human health. At its Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. The Grifols family of companies, including Grifols Inc., Grifols USA, Grifols Biologicals, Biomat USA and Plasma Collection Center, Inc. For more information, please visit our website: http://www.grifolsusa.com/. Grifols Inc. is the company that sets the corporate policies of all Grifols companies in the US (Grifols Biologicals, Biomat USA and Grifols USA). Also, it provides shared services on Human Resources, Information Technologies, Accounts Payables, Controlling, Audits, Planning and Finance and Regulatory Affairs. This company has an immediate opening for a Regulatory Affairs Manager offering an excellent benefits package, including medical, dental, vision, 401(K) plan, life insurance, educational assistance, and generous paid time off. Position Summary: ?Reports to the Regulatory Affairs (RA) Director. Incumbent must have excellent written and verbal communication skills, be well-organized, very detail-oriented, and be able to multi-task. The incumbent must be able to interact effectively within project teams to achieve group goals; and must have the ability to withstand pressure when work priorities change and/or timelines accelerate. The position requires negotiation of project completion timelines with internal commercial and external project leaders. Position requires continuous scheduling of activities and projects as demands and target dates change. Job Responsibilities: (This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.) ?Responsible for the planning, review and preparation of In Vitro Diagnostics (IVD) documents for pre-IDEs, premarket notification or 510(k), and BLA submissions to the CDRH, CBER, U.S. FDA. ?Review IVD performance studies for autoanalyzers and other clinical automation and analysis instrumentation, and diagnostic test kits related to immunology, blood banking, hemostasis and clinical diagnostic test kits in general. ?Be familiar with FDA-required standards, e.g., EP-A2, EP6-A, EP7-A2, EP9-A2, EP17-A. ?Alert management and information suppliers of gaps in the studies and provide recommendations and action items. ?Review FDA IVD guidance documents and update management of changes in the regulatory requirements which will impact the company. ?Project planning ? write project plans with target due dates to complete milestones. Monitor changes, inform relevant parties involved. Solve problems, take actions as required, and work in an efficient manner to ensure milestones are met by target dates. ?Represent the department in meetings, both regulatory and commercial in nature. Interact effectively with quality, regulatory, research personnel within the company, internal business managers and external suppliers/distributors in order to complete projects in a timely manner. ?Prepare electronic 510(k) submissions. ?Train personnel and write regulatory SOPs. Required Skills, Experience & Education: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). ?Mimimum of B.S. degree required. ?5 years minimum experience in regulatory submissions in the in vitro diagnostic device industry, preferably in immunology, blood banking, clinical chemistry and hemostasis, and with both instrumentation and reagents. ?Strong computer skills required. Knowledgeable in Access, Word, Excel, Statistical software, e.g., Analyse-It ?Excellent verbal and written communication skills ? must have technical writing ability. ?Strong interpersonal skills with ability to interact with personnel at all levels. ?Must be capable of multi-tasking with the ability to work well with others in a TEAM environment. To submit your resume please click or copy & paste the link below, or visit our Careers Website at www.grifolsusa.com http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&company_id=16052&jobid=216852&jobboardid=632

Job Title: Manager Regulatory Affairs Company: The Cambridge Group Ltd. Location: Highland Park, IL Description: Manager Regulatory AffairsThe Manager Regulatory Affairs will develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.  The candidate will represent or lead the RA function on assigned cross-functional project teams.  Monitor applicable regulatory requirements; assure compliance with company and external standards.  Establish appropriate communication within RA and other functions primarily at project level.  Perform gap analysis and propose solutions.  Develop and document sound regulatory decisions and justifications.  Ensure project teams and business objectives and deliverables are aligned with regulatory strategy. May provide direct supervision of individuals.  May review promotional material or SOP’s for compliance with local and global regulations.  The incumbent must have sound basis of Regulatory knowledge.  Documented 510(k) submission experience.  Solid scientific knowledge. Ability to manage complex projects and timelines in a matrix team environment.  Strong oral and written communication and presentation skills.  Demonstrated interpersonal skills including strong negotiation skills.  Ability to independently identify compliance risks and escalate when necessary. Ability to lead and coach others. A bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. A higher degree/PhD will be an advantage.  Up to 5% travel may be required.Please refer to job code SD7069 when responding to this ad.

Job Title: Science and Regulatory Affairs Director Company: McDonalds Location: Oak Brook, IL Description: About the Department: McDonald's Worldwide Supply Chain Management (WWSCM) department manages and executes strong working relationships with a global base of suppliers and AOW (Area of the World) product leaders. Worldwide Supply Chain strives to fuel system growth and value by providing best-in-class quality products and services at a competitive price through the deployment of resources tailored to manage each product category. The role of Worldwide Quality and Food Safety within WWSCM is to develop science-based standards, proactively engage on emerging issue management, and improve the customers experience across the counter through the delivery of Gold Standard quality. Job Description: As the Science and Regulatory Affair Director in the Worldwide Supply Chain Management of McDonald's Corporation, the prerequisites for this position are: Deep understanding of Food Science including Microbiology, Chemistry, Nutrition and Toxicology. Familiar with Food related regulations, guidelines, and references around the world. Able to aid the design of company's strategy on potential food related issues. Able to translate the science into potential impact on the business. Able to work with external and internal technical experts and business partners to effectively manage emerging issues around the world. Able to effectively communicate with internal and external stakeholders on food safety, quality and nutrition related policies, standards, and potential impact to McDonald's business. Productive team player willing to work with people with different cultural background. Effective on data analysis with Microsoft Office. Effective on project management. Willing to travel internationally. (30% international and 30% domestically) Minimum Requirements for position: Masters in food science, microbiology, chemistry, nutrition or related discipline required Bilingual preferred At least 7 to 10 years of experience in food related industry Strong familiarity with HACCP, CODEX, food safety and quality management systems Working knowledge of crisis management Strong computer skills with experience using Word, Excel, Power Point Strong verbal and written Communication skills required Experience in working in a strong team environment Demonstrate leadership in the areas of food safety and regulatory affairs Must have the ability to function within a team oriented environment and collaborate on multidisciplinary efforts