991 Fda jobs in the United States

Prometheus Federal Services (PFS) is seeking an Analyst to support initiatives at the Food and Drug Administration (FDA). In this role, you will work closely with and support federal agency clients on high-impact projects that advance public health outcomes. As an Analyst, you will apply analytic methodologies and principles to address client needs, contribute to strategic planning, and support the evaluation of project objectives. Your responsibilities will include data collection, stakeholder interviews, data modeling, project testing, and performance measurement. You will also assist in implementing solutions, tracking progress, and collaborating with internal teams and external partners to ensure successful project delivery. This is a fully on-site position. All work will be performed at 10903 New Hampshire Avenue, Building 51, 6th Floor, Silver Spring, MD 20993.

Essential Duties and Responsibilities:

• Support the development and maintenance of project plans, schedules, and deliverables under the guidance of senior team members.
• Assist in gathering, organizing, and analyzing program data to contribute to informed decision-making.
• Draft and assemble meeting materials, briefings, and status updates for internal use and FDA stakeholders.
• Contribute to identifying opportunities for process improvement and help implement recommended changes.
• Maintain accurate and well-organized documentation in alignment with project standards and requirements.
• Participate in team meetings and collaborate with colleagues to solve problems and achieve shared goals.

Minimum Qualifications:

• Bachelor's degree from an accredited college or university.
• Minimum of three (3) years of professional experience following completion of a bachelor's degree.
• Strong written and verbal communication skills.
• Proficiency in the Microsoft 365 suite, including Word, Excel, and PowerPoint.
• Ability to work both independently and collaboratively in a team-oriented environment.
• Authorized to work in the U.S. indefinitely without sponsorship.
• Ability to obtain a public trust.
• This is a fully on-site position. The candidate must commute to the work location Monday through Friday from 8:30 AM to 5:00 PM EST.

Preferred Qualifications:

• Bachelor's degree in Public Administration, Public Health, Business, or a similar field.
• Experience supporting the FDA or large health systems.
• Experience working for a consulting firm.

All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

This position may be subject to client or government vaccination, policy, or requirements that may change from time to time.

The work location is flexible if the company approves it, except that the position may not be performed remotely from Colorado.

PFS offers a comprehensive benefits package that includes health insurance, dental and vision insurance, flexible spending accounts, disability insurance, life insurance, a retirement plan, paid time off, remote work, and other benefits to accommodate what matters most to you and your family.

Date: Jul 16, 2025 Location: Ann Arbor Company: Wacker Chemical Corporation Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in Ann Arbor , we are looking for you as a(n) Senior Regulatory Affairs Specialist-FDA Food 1 1 . Position Overview: This position is responsible for managing all data submissions to the US FDA for Food, Food Contact and Cosmetic products, maintain global food facility registrations, provide support for FDA import classifications, as well as reviews of chemical formulations. This position will respond to product compliance requests and be required to utilize available government databases. This role will support Wacker business team members to ensure compliance to FDA, Food Chemicals Codex (FCC), Responsible Care and cosmetic standards and regulations. This position must be able to interpret and ensure compliance to all current and future FDA regulation requirements, must have working knowledge of food safety requirements under Food Safety Modernization Act (FSMA), hold certification as a (PCQI), and have certification in / or willingness to become certified as internal auditor for food and cosmetics. Job Responsibilities FDA Food Contact Program Management and Compliance : Responsible for managing Wacker's corporate FDA food contact program. Refine current procedures and strategy to accommodate growing business needs. Create and revise Wacker's Food Contact Evaluation letters for customers. Determinations made by reviewing chemical formulas for raw materials and Wacker formulations. Interface with Wacker Quality Management for review and signoff on Good Manufacturing Practices and food contact evaluation letters. Interface with 3rd party consultants for Food Contact Notifications. Provide technical support to 3rd party consultants for product notifications. Obtain quotes for outside food contact related legal opinions and consultation. Interface with FDA on product submissions, and track progress of their reviews. Manage submissions to third party certification organizations such as NSF International. Familiarity with Canadian Food laws and serving as the liaison between Wacker and our Canadian Regulatory Agent. Corporate FDA Food and Cosmetic Compliance Programs Responsible for ensuring Wacker regulatory compliance to FDA food and cosmetic regulations. Work with Corporate Departments to develop processes which ensure ongoing compliance to current FDA regulation requirements under all aspects of Food (including food contact) and cosmetic products produced or offered for sale in US. Maintain working relationship with Divisional Management to ensure compliance knowledge needs are met, as well as provide support and input for International regulatory requirements and external standards including USP-NF, Food Chemical Codex (FCC) where applicable. Familiarity with Canadian Food laws and serving as the liaison between Wacker and our Canadian Regulatory Agent. Obtain quotes for outside food contact related legal opinions and consultation. Interface with FDA on product submissions, and track progress of their reviews. Maintain and update Wacker's FDA Food facility registrations, as well as serve as interface for other interactions (Export certificates and filings). Communicate relevant updates to FDA current and proposed regulations to applicable Wacker departments and divisions. Divisional FDA Food and Cosmetic Compliance Programs Have basic working knowledge of Divisional product groups and end use applications for Wacker products and provide overarching guidance and interface with Divisional and Site Quality Managers and Business Team members to ensure compliance to current and upcoming FDA regulations, International regulatory requirements and external standards including USP-NF, FCC where applicable for each site. Participate in Wacker site internal, Regulatory, and 3rd party compliance audits. Provide support during FDA site inspections. Document Control: Ensure FDA compliance records are organized and maintained. Conduct internal compliance review to ensure FDA compliance letters, and supporting information are valid and up to date and reissued within the designated internal review cycle. Job Qualifications Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Food Science. Master's degree is preferred. 7+ years' experience Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents. Knowledge and experience in 21 CFR regulations involving GMP, Food Contact, Indirect Food Contact, Cosmetics, FDA Dietary Supplement approval, and GRAS determinations. Strong knowledge of 21 CFR Food Additive, Food Contact, Dietary Supplement, and Cosmetic Regulations Good knowledge of Generally Recognized As Safe (GRAS) requirements and FSMA, including inspection and audit processes Knowledge regarding GMP-Good Mfg. Practices and GDP-Good Documentation Practices. Ability to research, learn and properly apply information, such as standards/regulations, without direct supervision. Experience working in cross-functional teams. Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture. Experience in polymer chemistry is preferred. #LI-NTI What do we offer? WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. Compensation and Incentive plans Medical, Dental, and Vision Insurance effective day 1 Paid Time Off in addition to personal days and holidays Paid parental leave Wellbeing fund Flexible hybrid work arrangements 401(k) with company match Education Assistance Program Career development and advancement opportunities Support for Community Involvement We are looking forward to your online application at Reference Code:29593 #LI-NT1 The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including any type of US permanent residency (e.g., for a green card). Wacker is an Equal Opportunity Employer. We actively promote the equality of opportunity for all who are qualified and bring the requisite experience, talent, skill and potential, without regard to age, disability, sex, race, religion or belief, marriage/civil partnership, pregnancy/maternity, sexual orientation, or any other protected characteristics. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone. Nearest Major Market: Ann Arbor Nearest Secondary Market: Detroit #J-18808-Ljbffr

CORPORATE FDA REGULATORY ASSOCIATE (2327) Description Our client is seeking an experienced FDA regulatory associate to join their Healthcare & Life Sciences Practice Group in Washington, D.C. The ideal candidate will have a minimum of two years of experience advising clients on FDA regulatory matters, including transactional issues involving FDA-regulated entities. Preferred experience includes product development, clinical trials, launch and marketing, and interactions with government regulators throughout the FDA-regulated product life cycle. Candidates should possess outstanding writing skills and a desire to join a dynamic, diverse, and fast-paced practice area. Interested candidates are encouraged to apply below or confidentially reach out at Job #2327 KHAWAJA PARTNERS Will be in contact confidentially in 24-48hrs. Position Applied: Position Applied: CORPORATE FDA REGULATORY ASSOCIATE (2327) Upload your resume Max file size 10MB. Uploading. fileuploaded.jpg Upload failed. Max size for files is 10 MB. Thank you! Your submission has been received! Oops! Something went wrong while submitting the form. Talk to us on Signal State-of-the-art end-to-end encryption keeps your conversations secure. After you start an end-to-end encrypted chat, you can set a timer to have everyone's messages disappear at a time you choose after they've been seen. Use disappearing messages to keep your message history tidy. The message will disappear from all devices after the timer has elapsed. #J-18808-Ljbffr

Enjoy what you do while contributing to a company that makes a difference in people's lives. US Fertility, is one of the premier fertility centers in the United States, continually seeks experienced, compassionate, and dynamic team players who are committed to delivering exceptional patient care to join our growing practice.

The work we do building families offers stimulation, challenge, and personal reward. If you're looking for a new opportunity to work in a fast-paced, professional environment where your talent contributes to changing people's lives, then we want to talk to you.

We are seeking a detail-driven and proactive Regulatory Coordinator to join our Clinical Operations team. This mid-entry level position plays a vital role in maintaining compliance with FDA regulations related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including oversight of screening, testing, and documentation for egg and sperm donors. The Regulatory Coordinator ensures adherence to federal and state requirements, supports inspections, and partners closely with clinical and operational teams to uphold regulatory integrity.

We have an immediate opening for a full-time Regulatory Coordinator working Hybrid M-F 8am-5pm.

How You'll Contribute:

We always do whatever it takes, even if it isn't specifically our "job." In general, the position is responsible for:

• Regulatory Oversight & Compliance
• Ensure FDA-required donor screening and testing are completed within required timeframes.
• Review and track laboratory results and documentation to confirm FDA eligibility determinations.
• Monitor and maintain compliance with 21 CFR Part 1271 and state tissue bank regulations.
• Support FDA and state inspections, including preparation of documents, sta4 coordination, and response plans.
• Documentation & Audit
• Conduct quality assurance (QA) and quality control (QC) audits of donor records, physical exam forms, and test results.
• Identify gaps or inconsistencies in documentation and escalate appropriately.
• Ensure accurate recordkeeping in alignment with FDA regulations and internal policies.
• Training & Process Improvement
• Collaborate with clinical operations leaders to identify compliance-related training needs.
• Assist in developing and delivering targeted training based on sta4 performance and regulatory requirements.
• Participate in performance improvement initiatives and internal audits.
• SOPs and Policy Management
• Draft, revise, and maintain standard operating procedures (SOPs), policies, and job aids related to donor eligibility, lab testing, and compliance.
• Ensure all updates reflect current regulatory guidance and best practices.
• Cross-Functional Collaboration
• Work closely with clinical teams, laboratory sta4, and third-party vendors to ensure timely coordination of testing, documentation, and eligibility reviews.
• Support other departments during audits or regulatory reviews.

• Bachelor's degree in a health sciences, biology, public health, or related field (or equivalent experience).
• Minimum 1-2 years of experience in regulatory, compliance, clinical operations, or laboratory coordination.
• Prior experience in reproductive medicine, IVF, or tissue banking is strongly preferred.
• Working knowledge of FDA HCT/P regulations, particularly 21 CFR Part 1271.
• Familiarity with donor eligibility determination processes.
• Exceptional attention to detail with a commitment to accuracy and documentation integrity.
• Strong critical thinking and problem-solving skills.
• Ability to understand both granular detail and broader organizational impact.
• Professional communication skills, including clear written documentation and e4ective crossfunctional collaboration
• Ability to manage time e4ectively and work independently within defined regulatory timelines.
• Proven ability to write and maintain SOPs and procedural documents.
• Comfort working in a fast-paced environment with shifting regulatory priorities.

• Competitive pay + bonus
• Comprehensive training
• Medical, dental, vision, and 401(k) matching
• Generous paid time off and holidays
• Retirement plan
• Tuition assistance
• Ability to make an impact in the communities we serve

Job DescriptionJob DescriptionDescription:

Location: Statewide, North Carolina
Job Type: Part-Time, Temporary
Headquarters: New Carrollton, MD

Overview

The Bizzell Group is seeking Underage Purchasers (ages 1820) to assist in undercover tobacco compliance inspections at retail locations across North Carolina. This position plays a critical role in supporting federal and state regulatory enforcement by ensuring retailers comply with tobacco sales laws under the Family Smoking Prevention and Tobacco Control Act and the FDA Tobacco Inspection Program.

Requirement (Bona Fide Occupational Qualification BFOQ):
Applicants must be between 18 and 20 years old at the time of application. This requirement is legally necessary and qualifies as a BFOQ under federal anti-discrimination laws, as the role specifically involves attempting to purchase tobacco as a minor under the legal of 21. Compliance operations require individuals who are under 21 to assess retailer adherence to federal and state regulations.

Key Responsibilities

Compliance Inspections

• Accompany an FDA-commissioned inspector to designated retail locations to assess compliance with tobacco sales regulations.
• Attempt to purchase tobacco products while strictly adhering to FDA compliance protocols and procedural guidelines.
• Maintain professionalism, confidentiality, and discretion to ensure unbiased compliance assessments.

Documentation & Reporting

• Provide detailed and accurate reports on each inspection, documenting interactions, retailer responses, and any observed violations.
• Ensure compliance with FDA and North Carolina Department of Health and Human Services (NC DHHS) regulations for the tobacco retail inspection program.

Training & Compliance Adherence

• Successfully complete all FDA-required training to ensure proper adherence to inspection protocols and compliance standards.
• Follow chain of custody procedures for any collected evidence.
• Participate in refresher training sessions and program evaluations as required by the FDA Tobacco Inspection Program.

Skills & Competencies

• Strong attention to detail and ability to strictly follow compliance protocols.
• Effective observational and communication skills for documenting inspection results.
• Ability to maintain confidentiality and professionalism in all inspection activities.
• Availability to work flexible hours and travel locally as required.

Why Join Us?

• Gain valuable experience in federal compliance enforcement and regulatory inspections.
• Contribute to public health and safety by ensuring compliance with tobacco control laws.
• Work as part of a highly trained team committed to upholding state and federal regulatory standards.

Interested candidates should submit their resume and application for consideration.

Requirements:

Eligibility Criteria

• Requirement (BFOQ Justification): Must be between 18 and 20 years old at the time of application. This is a legally required condition for performing job duties.
• Required to pass the NC state background check
• Must have a valid drivers license and reliable transportation for travel to assigned retail locations.

We are looking for a Director Product Counsel for the Regeneron Regulatory and Commercial Law team to provide proactive and collaborative legal advice and counsel in connection with the commercialization of one or more of Regeneron's products, including support for our leading product in the allergic and inflammatory disease therapeutic area. Counsel will be embedded as a core team member, serving as a strategic legal advisor to multiple internal partners, including the commercial, medical affairs, regulatory, HEOR, corporate affairs, and compliance teams. Counsel will advise our internal partners through a deep understanding of (i) the complex laws and regulations and (ii) business and strategic objectives related to the discovery, development, and commercialization of biotechnology products. The ideal candidate will have relevant in-house experience counseling on an approved product with anticipated newly approved indications, and providing practical and strategic legal advice on a broad range of issues.

A typical day might include:

• Providing day-to-day strategic and business-focused legal and risk counseling for one or more of Regeneron's products/product candidates, from development through commercialization, including advising on a broad range of healthcare regulatory matters, including labeling negotiations, advertising and promotion, drug safety, market research, scientific exchange, market access and patient support initiatives, and interactions with healthcare professionals and patients.
• Demonstrating a solid understanding of the strategic and tactical objectives of the client teams supported, and advising on strategic brand and medical planning, developing creative and innovative solutions to key initiatives, considering the business objectives and priorities, as well as the US and/or international legal and regulatory landscape.
• Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning.
• Ensuring compliance with all relevant laws, regulations, policies, procedure and controls within relevant business areas supported.
• Advising on data disclosures following clinical development achievements via press releases and US or international medical congresses and scientific exchange aligned with applicable laws and regulations.
• Liaising with other Law Department functions both in the US and globally, including litigation, IP, Compliance, and Transactions, to ensure integrated legal support and timely updates and information sharing.
• Reviewing relevant draft scientific publications and providing guidance as appropriate.
• Providing additional legal support on various matters for the Regulatory and Commercialization Law Team.

This role might be for you if you have:

• A solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory environment (including healthcare fraud and abuse, anti-kickback, and competition law) as practiced by a multinational pharmaceutical manufacturer.
• Deep knowledge of applicable statutory and regulatory frameworks governing the sale and marketing of biopharmaceuticals.
• Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred.

We are looking for at least 3 years of legal experience at a nationally recognized law practice, (preferred in-house biotech/pharmaceutical and/or healthcare experience) and be licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. We also require a JD with excellent law school credentials. Some travel is required (US and limited international). This role requires working onsite a minimum of 3 days per week.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually)

$202,000.00 - $336,600.00