Top 15693 U.S. Fda Jobs

Senior Associate, Regulatory Affairs (US)
BeiGene —Remote
- $93,600 - $123,600 a year
- Full-time
- Microsoft Excel
- 5 years
- Computer literacy
- Health savings account
- Employee stock purchase plan
Medical Content Specialist (Contract)
Everlywell —Remote
- $45 - $55 an hour
- Part-time
- Remote
- Clinic experience
- Mid-level
- 3 years
Clinical Research Associate (US-based, East Coast)
CCS Associates —San Jose, CA
- Bachelor of Science
- Writing skills
- Mid-level
Clinical Research Associate (US-based, West Coast)
CCS Associates —San Jose, CA
- Bachelor of Science
- Writing skills
- Mid-level
Contractor- Patient Recruitment Specialist (Remote, U.S.)
Profound Research —Remote
- Full-time
- Hybrid work
- Mid-level
- Associate's degree
- CNA
- Health insurance
- Paid time off
Quick Apply
Remote Insurance Verification Specialist, Specialty (Michigan)
Walgreens —Remote
- Remote
- Computer literacy
- Mid-level
- Windows
Senior Associate, US Regulatory Affairs
BeiGene —Remote
- $93,600 - $123,600 a year
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health savings account
- Employee stock purchase plan
11d
DRUG SAFETY ASSOCIATE
Zenith LifeScience —South Plainfield, NJ
- $60,000 - $70,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- 1 year
Amazon Compliance Specialist
Kitsch LLC —Remote
- Full-time
- Remote
- Mid-level
- 3 years
- Training & development
Country Managing Director, U.S.
PINDAO INTERNATIONAL INVESTMENT PTE. LTD. —New York, NY
- $120,000 - $200,000 a year
- Full-time
- Bachelor's degree
- Quick service & fast food restaurant
- US work authorization
- 401(k)
- Paid time off
Quick Apply
13d
Process Development and Operations Support Manager
ALK-Abello, Inc —Post Falls, ID
- $90,000 - $125,000 a year
- Full-time
- OSHA
- 5 years
- Bachelor's degree
- 401(k) matching
Quick Apply
Experienced Customs Entry Writer / Import Specialist
NELSON INTERNATIONAL INC —Norfolk, VA
- $30 - $40 an hour
- Full-time
- Background check
- Writing skills
- Research
- Health insurance
- Dental insurance
Quick Apply
USP 795 (Non-Sterile) Pharmacist Department Manager
Buy-Rite Drugs —Hartselle, AL
- $110,000 - $125,000 a year
- Full-time
- Background check
- Patient care
- Computer skills
- 401(k)
- Paid time off
Quick Apply
Interventional Psychiatrist
Radial —New York, NY
- $300,000 - $350,000 a year
- Full-time
- Hybrid work
- Medicine
- Psychiatry
- Addiction Medicine
- Health insurance
- Dental insurance
Quick Apply
Technical Product Development Manager
Lumijes Technologies —Gainesville, FL
- Full-time
- Hybrid work
- Background check
- Product management
- Senior level
Quick Apply
12d
Licensed Customs Broker- SEA, WA
Coppersmith Global Logistics —SeaTac, WA
- $72,000 - $90,000 a year
- Full-time
- Office
- Microsoft Office
- Supervising experience
- Profit sharing
- Disability insurance
Quick Apply
5d
Validation Engineer (OPT/CPT)
Validation Associates LLC —Herndon, VA
- $30 - $33 an hour
- Contract
- Engineering
- Mid-level
- Analysis skills
- Relocation assistance
- Health insurance
Quick Apply
14d
Sterile Compounding Pharmacist (IV / USP 797) – 503A Pharmacy
Allay Meds —San Antonio, TX
- $120,000 - $145,000 a year
- Full-time
- Management
- Bachelor of Science
- Bachelor's degree
- Relocation assistance
- Health insurance
Quick Apply
Quality Assurance Manager
JimmyBar —Elk Grove Village, IL
- From $75,000 a year
- Full-time
- 5 years
- Office
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
Regulatory Affairs Specialist
elliquence, LLC —Baldwin, NY
- $75,000 - $85,000 a year
- Full-time
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply

I want to receive the latest job alert for U.S. Fda

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

U.S. Fda jobs near

Insurance Verification Specialist jobs in Remote

Clinical Research Associate jobs in San Jose, CA

Regulatory Affairs Specialist jobs in Remote

Content Specialist jobs in Remote

Psychiatrist jobs in New York, NY

Validation Engineer jobs in Herndon, VA

Country Manager jobs in New York, NY

Compliance Officer jobs in Remote

Insurance Verification Specialist jobs in Tacoma, WA

Insurance Verification Specialist jobs in Frisco, TX

Insurance Verification Specialist jobs in Cobleskill, NY

Remote Insurance jobs in Raleigh, NC

Insurance Verification Specialist jobs in Des Moines, IA

Mobile Police Department jobs in Alabama

Department Manager jobs in Cincinnati, OH

Department Manager jobs in Philadelphia, PA

Fire Department jobs in Newark, NJ

Department Manager jobs in Houston, TX

Emergency Department Technician jobs in Frisco, TX

Health Department jobs in Charlotte, NC

Senior Associate, Regulatory Affairs (US)

BeiGene -
Remote

Apply Now

Job Details

Full-time
$93,600 - $123,600 a year

Benefits

Health savings account
Employee stock purchase plan
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
Life insurance

Qualifications

FDA submissions
Investigational new drug (IND) applications

Full Job Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements.

The role assumes end‑to‑end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands‑on mindset, as well as the ability to operate as a flexible, collaborative team player who is open to learning and adapting in a fast‑paced, deadline‑driven environment.

This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements; it is not an entry‑level position.

Essential Functions of the Job:

Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance.
Draft regulatory submission documents (e.g., IND components) as required.
Review regulatory documentation to ensure accuracy, consistency, and completeness, and supports the effective execution of regulatory submissions to health authorities.
Serve as the primary execution lead and cross‑functional coordinator for assigned U.S. regulatory submissions, ensuring clarity of roles, timelines, and deliverables.
Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies.
Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and to collect and organize FDA submission-ready documents.
Perform Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements.
Liaise with Regulatory Publishing to support on‑time, first‑cycle‑quality FDA submissions.
Maintain IND, NDA, and BLA submission archives ensuring version control, document integrity, and inspection readiness.
Request FDA application numbers via the CDER NextGen Portal and support FDA correspondence tracking.
Utilize regulatory tracking tools (e.g., Veeva Vault RIM, submission trackers) to monitor milestones, deliverables, and risks.
Monitor FDA guidance updates and contribute to continuous improvement of US submission processes.

Supervisory Responsibilities:

None

Computer Skills:

Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools.
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Ability to manage submission timelines, trackers, and Master Document Lists.
Proficiency in Microsoft Office.

Other Qualifications:

BA/BS degree, preferably in a scientific or health‑related discipline with 2+ years OR 5+ years of Regulatory Affairs experience, including hands‑on support of U.S. IND preparation required.
Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional.
Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable.
Assist regulatory affairs team/strategist in supporting strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
Demonstrates sound judgment and practical business awareness in supporting regulatory activities and execution decisions.
Demonstrates ability to function as a trusted cross‑functional partner in a matrixed regulatory environment.
The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
Hands‑on, execution‑driven mindset with accountability for deliverables and outcomes.
Clear written and verbal communication with cross-functional teams.
Ability to work independently and collaboratively under tight FDA-driven timelines.
Strong organizational and documentation skills
Ability to manage multiple US submissions and priorities simultaneously

Travel: N/A

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

Salary Range: $93,600.00 - $123,600.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].

Apply Now

Refine Your Search

U.S. Fda jobs

Senior Associate, Regulatory Affairs (US)

Medical Content Specialist (Contract)

Clinical Research Associate (US-based, East Coast)

Clinical Research Associate (US-based, West Coast)

Contractor- Patient Recruitment Specialist (Remote, U.S.)

Remote Insurance Verification Specialist, Specialty (Michigan)

Senior Associate, US Regulatory Affairs

DRUG SAFETY ASSOCIATE

Amazon Compliance Specialist

Country Managing Director, U.S.

Process Development and Operations Support Manager

Experienced Customs Entry Writer / Import Specialist

USP 795 (Non-Sterile) Pharmacist Department Manager

Interventional Psychiatrist

Technical Product Development Manager

Licensed Customs Broker- SEA, WA

Validation Engineer (OPT/CPT)

Sterile Compounding Pharmacist (IV / USP 797) – 503A Pharmacy

Quality Assurance Manager

Regulatory Affairs Specialist

I want to receive the latest job alert for U.S. Fda

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected