Support FDA submissions, amendments, annual reports, supplements, and regulatory correspondence. * Ensure manufacturing, packaging, labeling, and documentation activities comply with FDA and cGMP ...
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Support FDA submissions, amendments, annual reports, supplements, and regulatory correspondence. * Ensure manufacturing, packaging, labeling, and documentation activities comply with FDA and cGMP ...
Quick apply
Support FDA submissions, amendments, annual reports, supplements, and regulatory correspondence. * Ensure manufacturing, packaging, labeling, and documentation activities comply with FDA and cGMP ...
Must understand FDA regulations.
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Must understand FDA regulations.
Own regulatory compliance (FDA / food contact / global) for coatings and packaging materials. Provide technical leadership in coating development, performance, and customer application This position ...
Own regulatory compliance (FDA / food contact / global) for coatings and packaging materials. Provide technical leadership in coating development, performance, and customer application This position ...
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
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Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
Indianapolis, IN · On-site
Any Must have: GMP-regulated biopharmaceutical environment, QMR, APQR, FDA/ICH/EU cGMP Description: GMP Experience * Minimum 8+ years in a GMP-regulated biopharmaceutical environment Quality ...
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Indianapolis, IN · On-site
Any Must have: GMP-regulated biopharmaceutical environment, QMR, APQR, FDA/ICH/EU cGMP Description: GMP Experience * Minimum 8+ years in a GMP-regulated biopharmaceutical environment Quality ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
... FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs. • Oversee process-related change controls to ensure appropriate ...
... FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs. • Oversee process-related change controls to ensure appropriate ...
... FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs. • Oversee process-related change controls to ensure appropriate ...
... FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs. • Oversee process-related change controls to ensure appropriate ...
... FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs. • Oversee process-related change controls to ensure appropriate ...
Quick apply
... FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs. • Oversee process-related change controls to ensure appropriate ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
Quick apply
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA ...
Plainfield, IN · On-site
$15.25 - $17.50/hr
Warehouse Pick, pack Ship Material Upload Receipt or order OSHA, FDA, DEA Warehouse Packer Operator duties: Support the order processing function (i. e. , picking, packing, shipping, etc. ). Receive ...
Plainfield, IN · On-site
$15.25 - $17.50/hr
Warehouse Pick, pack Ship Material Upload Receipt or order OSHA, FDA, DEA Warehouse Packer Operator duties: Support the order processing function (i. e. , picking, packing, shipping, etc. ). Receive ...
Avon, IN · On-site
Overview The Compliance Coordinator II is responsible for document compliance with FDA regulations and company standards as well as providing staff support related to documentation and records. Job ...
Avon, IN · On-site
Overview The Compliance Coordinator II is responsible for document compliance with FDA regulations and company standards as well as providing staff support related to documentation and records. Job ...
Columbus, IN · On-site
$15 - $18.25/hr
This includesaccurate recordkeeping, excellent customer service, and adherence to DOT/FDA/OSHA/Lincare safety standards. JOB FUNCTIONS: * Makes oxygen deliveries (liquid oxygen, cylinder, and ...
Columbus, IN · On-site
$15 - $18.25/hr
This includesaccurate recordkeeping, excellent customer service, and adherence to DOT/FDA/OSHA/Lincare safety standards. JOB FUNCTIONS: * Makes oxygen deliveries (liquid oxygen, cylinder, and ...
Indianapolis, IN · On-site
$143K - $189K/yr
Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs * Drive high-quality communications with FDA that clearly articulate Lilly's scientific position * Build and ...
Indianapolis, IN · On-site
$143K - $189K/yr
Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs * Drive high-quality communications with FDA that clearly articulate Lilly's scientific position * Build and ...
$12.62 - $18.03
11% of jobs
$22.40 is the 25th percentile. Wages below this are outliers.
$18.03 - $23.44
18% of jobs
$23.44 - $28.84
16% of jobs
The median wage is $31.55 / hr.
$28.84 - $34.25
12% of jobs
$34.25 - $39.66
11% of jobs
$43.72 is the 75th percentile. Wages above this are outliers.
$39.66 - $45.07
12% of jobs
$45.07 - $50.48
9% of jobs
$50.48 - $55.89
5% of jobs
$55.89 - $61.29
3% of jobs
$61.29 - $66.70
2% of jobs
$66.70 - $72.11
2% of jobs
$12
$36
$72
| Aspect | Fda | Food Scientist |
|---|---|---|
| Required Credentials | Typically a degree in health, science, or related field; certifications vary | Bachelor's or master's in food science, microbiology, or related |
| Work Environment | Regulatory agencies, laboratories, inspection sites | Food manufacturing facilities, laboratories, research settings |
| Employer & Industry Usage | U.S. Food and Drug Administration, government agencies | Food companies, research institutions, government agencies |
| Common Search & Comparison Intent | Understanding regulatory roles, compliance, and enforcement | Food safety, product development, research |
While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

Job Title: Regulatory Affairs Specialist
Location: Indiana, USA
Duration: Long-term
Job Summary
The Regulatory Affairs Specialist will support regulatory compliance activities for pharmaceutical manufacturing operations. The role is responsible for preparing, reviewing, and maintaining regulatory documentation, supporting FDA submissions, ensuring cGMP compliance, coordinating with Quality, Manufacturing, Validation, Packaging, and Supply Chain teams, and helping maintain product compliance throughout the manufacturing lifecycle.
Key Responsibilities
Skills Required
Preferred Qualifications
Sourced by ZipRecruiter
51 - 200 Employees
Iselin, NJ, US
2018