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Fda Project Jobs in Chicago, IL (NOW HIRING)

Experience5+ years? experience working on capital expenditure projects as project manager,Food Industry requiredDairy process preferredMinimum of 3 years of USDA or FDA regulated plant experience ...

Project Manager, R&D

Deerfield, IL · On-site

$120K - $165K/yr

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

Lead teams in defining project strategies, establishing goals, and ensuring project scope is ... Familiarity with FDA regulatory pathways (e.g., 510(k), combination products). * Proven ability to ...

We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...

Manager Regulatory Compliance

Northfield, IL

$116K - $174K/yr

  • Medical

  • Life

  • Retirement

  • PTO

Strong communication and project coordination skills * Experience supporting FDA audits or internal quality audits Preferred Job Requirements: Work Experience * 5+ years of direct experience with ...

Showing results 41-60

Fda Project information

What is an FDA project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are the key skills and qualifications needed to thrive as an FDA project manager?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What cities near Chicago, IL are hiring for Fda Project jobs?

Cities near Chicago, IL with the most Fda Project job openings:

Sr. Packaging Project Manager

Lactalis USA

Chicago, IL

Full-time

Retirement, PTO

Re-posted 3 days ago


Lactalis USA rating

7.9

Company rating: 7.9 out of 10

Based on 40 frontline employees who took The Breakroom Quiz

100th of 438 rated food and drinks producers


Job description

DescriptionReady for more than just a job? Build a career with purpose.At Lactalis in the USA, we?re committed to providing meaningful opportunities for our people to learn, grow, and thrive whether you?re just starting your journey with us or looking to take the next step in your career. From day one, we offer the tools and support to help you succeed. As the world leader in dairy, Lactalis is a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Each day, we?re proud to produce award-winning dairy products that bring people together. In the US, we proudly offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, Prsident specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone?s cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi?s, Stonyfield Organic, Brown Cow , Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with a growing family of ethnic favorites like Karoun, Gopi, and Arz.At Lactalis, we live by our core values Ambition, Engagement, and Simplicity. We foster a workplace where innovation thrives, diverse perspectives are celebrated, and everyone?s unique background and ideas are valued. Even if you don?t meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us shape the future of dairy.                                       From your PASSION to oursLactalis Heritage Dairy, part of the Lactalis family of companies, is currently hiring a Sr. Packaging Project Manager based in Chicago, Illinois. The Sr. Packaging Project Manager is responsible for managing and leading projects related to the packaging of our Yogurt, cheeses and powder products, from design to full implementation and support the plant production and quality operations. Working with Operations, Research and Development, the Project Manager will be responsible for optimizing the various production systems, which directly and indirectly support the manufacturing process by implementing new process or modifying actual process. Will be involved with existing and new processes in the company. The position will be based in one of the main manufacturing sites Londonderry NH, Buffalo NY, Nampa ID, Tulare CA or in the corporate office located in Chicago Il.Travel will be required up to 50% of the time to plants based in NY, WI, CA, ID, NH, VT, AZ, TN & MI or to manufacturers/vendors site locations nationally and internationally. From your EXPERTISE to oursKey responsibilities for this position include:Develop drawings, scopes of work, budgets and timelines as needed to prepare a project for submittal.Source vendors, negotiate and acquire quotes for project investments.Source, negotiate and acquire quotes for budgetary needsManage projects,Track projects cost and maintain them within budget,Coordinate project review meetings to include setting them up, keeping meeting notes, and reporting out results to key stakeholders.Manage principles for the effective execution of projects,Work cross-functionally to ensure projects meet the needs of all key stakeholders to include but not be limited to Quality, Food Safety, Planning, Operations, and Maintenance.Attend Factory Acceptance Tests as required to validate equipment purchases.Lead and assist in the development of the annual capital budget,Travel and / or extended or off work hours may be required based on project needs,This description reflects management?s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.To fulfill these responsibilities, tools such as a computer, phone or, and / or allowance(s) may be provided.Reasonable accommodations may be made to enable individuals with disabilities to perform these Essential Duties and Responsibilities. Requirements  From your STORY to oursQualified applicants will contribute the following:EducationBachelor?s degree in mechanical or chemical engineering.Experience5+ years? experience working on capital expenditure projects as project manager,Food Industry requiredDairy process preferredMinimum of 3 years of USDA or FDA regulated plant experience supporting manufacturing and utilitiesSpecialized KnowledgeMicrosoft Office, Advanced Excel skills; macros, pivot tables, AutoCAD (equipment & P&ID dwg)Skills / AbilitiesStrong attention to detailAbility to audit, investigate and improve packaging machinery,Effectively communicate to internal and external customers,Prioritization, organization, time management, and follow-up skills,Continuous improvement mindset,Ability to work with minimum of supervision,Ability to travel to plant and machine manufacturers sites nationally and internationally.At Lactalis, we offer a comprehensive Total Rewards Program with a variety of affordable benefits and coverage options. We support insurance costs significantly, contribute generously to retirement plans, and offer Paid Time Off from day one. We are committed to your professional growth, providing training and development opportunities, including Education Reimbursement. Join us and grow your career.Lactalis is an equal employment opportunity employer. We will not discriminate against applicants with regard to any legally-recognized basis including, but not limited to: veteran status, race, color, religion, sex, national origin, age, marital status, sexual orientation, and physical or mental disabilities. Further, any division of the Company that is an Affirmative Action Employer will comply with all related legal obligations.

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