Regulatory Affairs Specialist II - Labeling and Promotion Classification: Exempt Reports to: Regulatory Affairs Manager Summary/Objective The Regulatory Affairs Specialist II is responsible for ...
Regulatory Affairs Specialist II - Labeling and Promotion Classification: Exempt Reports to: Regulatory Affairs Manager Summary/Objective The Regulatory Affairs Specialist II is responsible for ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. * Support ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. * Support ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. * Support ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. * Support ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. Support cross ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. Support cross ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. * Support ...
Review and approve product formulas, ingredient lists, packaging artwork, labels, and digital content for regulatory compliance with U.S. and Canadian regulations and Company policies. * Support ...
Provide ongoing regulatory support for existing products, including formula/label updates and issue resolution. * Monitor regulatory changes (e.g., federal, state, global trends) and translate ...
Provide ongoing regulatory support for existing products, including formula/label updates and issue resolution. * Monitor regulatory changes (e.g., federal, state, global trends) and translate ...
Provide ongoing regulatory support for existing products, including formula/label updates and issue resolution. * Monitor regulatory changes (e.g., federal, state, global trends) and translate ...
Provide ongoing regulatory support for existing products, including formula/label updates and issue resolution. * Monitor regulatory changes (e.g., federal, state, global trends) and translate ...
Regulatory Compliance & Quality: Ensure adherence to global medical device labeling, packaging, and design control requirements * Execution & Delivery: Ensure on-time, high-quality delivery of ...
Regulatory Compliance & Quality: Ensure adherence to global medical device labeling, packaging, and design control requirements * Execution & Delivery: Ensure on-time, high-quality delivery of ...
R&D Scientist 1
Tifton, GA · Hybrid
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
R&D Scientist 1
Tifton, GA · Hybrid
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
Regulatory Compliance & Quality: Ensure adherence to global medical device labeling, packaging, and design control requirements * Execution & Delivery: Ensure on-time, high-quality delivery of ...
Regulatory Compliance & Quality: Ensure adherence to global medical device labeling, packaging, and design control requirements * Execution & Delivery: Ensure on-time, high-quality delivery of ...
R&D Scientist 1
Tifton, GA · On-site
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
R&D Scientist 1
Tifton, GA · On-site
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
R&D Scientist 1
Tifton, GA · Hybrid
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
R&D Scientist 1
Tifton, GA · Hybrid
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
Senior Director I, Scientific & Regulatory Affairs - Compliance & Innovation
Atlanta, GA · On-site
$144K - $190K/yr
S. food and beverage regulations, including FDA and any state requirements related to labeling, claims, standards of identity, and overall compliance. * Lead regulatory strategies to support ...
Senior Director I, Scientific & Regulatory Affairs - Compliance & Innovation
Atlanta, GA · On-site
$144K - $190K/yr
S. food and beverage regulations, including FDA and any state requirements related to labeling, claims, standards of identity, and overall compliance. * Lead regulatory strategies to support ...
Senior Director I, Scientific & Regulatory Affairs - Compliance & Innovation
Atlanta, GA · On-site
$144K - $190K/yr
S. food and beverage regulations, including FDA and any state requirements related to labeling, claims, standards of identity, and overall compliance. * Lead regulatory strategies to support ...
Senior Director I, Scientific & Regulatory Affairs - Compliance & Innovation
Atlanta, GA · On-site
$144K - $190K/yr
S. food and beverage regulations, including FDA and any state requirements related to labeling, claims, standards of identity, and overall compliance. * Lead regulatory strategies to support ...
Regulatory Compliance & Quality: Ensure adherence to global medical device labeling, packaging, and design control requirements * Execution & Delivery: Ensure on-time, high-quality delivery of ...
Regulatory Compliance & Quality: Ensure adherence to global medical device labeling, packaging, and design control requirements * Execution & Delivery: Ensure on-time, high-quality delivery of ...
Senior Director I, Scientific & Regulatory Affairs - Compliance & Innovation
Atlanta, GA · On-site
$144K - $190K/yr
S. food and beverage regulations, including FDA and any state requirements related to labeling, claims, standards of identity, and overall compliance. * Lead regulatory strategies to support ...
Senior Director I, Scientific & Regulatory Affairs - Compliance & Innovation
Atlanta, GA · On-site
$144K - $190K/yr
S. food and beverage regulations, including FDA and any state requirements related to labeling, claims, standards of identity, and overall compliance. * Lead regulatory strategies to support ...
R&D Scientist 1
Tifton, GA · Hybrid
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
Quick apply
R&D Scientist 1
Tifton, GA · Hybrid
Provide technical expertise through training, demonstrations, and scientific documentation to support product positioning, customer education, and regulatory labeling initiatives. Qualifications * M.
Revise labeling as requested by the FDA, internal and external partners, or to conform to changes ... Actively train on new regulations and in governmental agency webinars to increase regulatory ...
Revise labeling as requested by the FDA, internal and external partners, or to conform to changes ... Actively train on new regulations and in governmental agency webinars to increase regulatory ...
Senior Director, Regulatory Affairs
Alpharetta, GA · On-site
$146K - $193K/yr
Oversee regulatory submissions for product changes, labeling updates, manufacturing transfers, and renewals. Regulatory Compliance * Ensure ongoing compliance with global regulatory requirements ...
Senior Director, Regulatory Affairs
Alpharetta, GA · On-site
$146K - $193K/yr
Oversee regulatory submissions for product changes, labeling updates, manufacturing transfers, and renewals. Regulatory Compliance * Ensure ongoing compliance with global regulatory requirements ...
Understanding of food regulations to ensure compliance on labeling Qualifications * PhD/MS in Applied Biological Sciences, Nutrition, Food Science, Food Safety/Toxicology, or other relevant subjects ...
Understanding of food regulations to ensure compliance on labeling Qualifications * PhD/MS in Applied Biological Sciences, Nutrition, Food Science, Food Safety/Toxicology, or other relevant subjects ...
Regulatory Labeling information
See Georgia salary details
$13.36 is the 25th percentile. Wages below this are outliers.
$10.96 - $17.29
66% of jobs
$17.29 - $23.62
6% of jobs
$26.26 is the 75th percentile. Wages above this are outliers.
$23.62 - $29.95
6% of jobs
$29.95 - $36.28
7% of jobs
$36.28 - $42.61
5% of jobs
$42.61 - $48.94
5% of jobs
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1% of jobs
$55.26 - $61.59
0% of jobs
$61.59 - $67.92
0% of jobs
$67.92 - $74.25
1% of jobs
$74.25 - $80.58
1% of jobs
$10
$25
$80
How much do regulatory labeling jobs pay per hour?
What is regulatory labeling?
What are some common challenges faced in a regulatory labeling role, and how can they be managed?
What are the key skills and qualifications needed to thrive as a regulatory labeling specialist, and why are they important?
What is the difference between Regulatory Labeling vs Regulatory Documentation?
| Aspect | Regulatory Labeling | Regulatory Documentation |
|---|---|---|
| Purpose | Ensures product labels meet regulatory standards and communicate necessary information to consumers and authorities. | Prepares comprehensive reports, submissions, and records required for regulatory approval and compliance. |
| Work Environment | Primarily office-based, collaborating with marketing, legal, and regulatory teams. | Office and laboratory settings, often involving detailed technical writing and data compilation. |
| Required Credentials | Typically requires a degree in life sciences, regulatory affairs, or related fields; certifications like RAC are common. | Similar credentials, often with advanced degrees or certifications in regulatory affairs or quality assurance. |
While both roles focus on compliance, Regulatory Labeling concentrates on product labels and packaging, ensuring they meet legal standards. Regulatory Documentation involves creating detailed reports and submissions for regulatory approval. Both roles require similar qualifications and often work together to ensure product compliance throughout the development and marketing process.
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For Regulatory Labeling jobs in Georgia, the most frequently searched job titles are:
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The top searched job categories for Regulatory Labeling jobs in Georgia are:
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Regulatory Affairs Specialist II - Labeling & Promotion
Alpharetta, GA • On-site
Other
Re-posted 6 days ago
Job description
Position Title: Regulatory Affairs Specialist II – Labeling and Promotion
Classification: Exempt
Reports to: Regulatory Affairs Manager
Summary/Objective
The Regulatory Affairs Specialist II is responsible for independently preparing submissions in eCTD format, label and promotions participant for Regulatory Affairs in client meetings, interact with the various governmental agencies when needed, and assess promotional and labeling changes for regulatory impact.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Generate, review and approve labeling, packaging, artwork, instructions for use (IFUs), and related documentation to ensure compliance with applicable regulations and approved registrations.
- Support review and approval of promotional, educational, and marketing materials in accordance with regulatory and internal requirements.
- Independently prepare complete submissions in eCTD format according to supplied checklist(s) – Label supplements, OPDP materials, Annual Reports, and other product correspondence as needed.
- Collaborate with cross-functional teams to support development and production
- Proactively work with clients to ensure successful working relationship by providing documentation and information in a timely manner
- Assess filing impact of RLD changes, client requested changes, and associated documents as well as conformance to submission requirements.
- Maintain SPL in CDERDirect and perform annual certifications.
- Assist in training associates in preparation of submissions.
- Interact with the various Agencies (FDA, DEA, TCEQ, etc.) in audits and other meetings as needed.
- Contribute to process improvements, SOP updates, and regulatory best practices.
- Other duties as assigned.
Supervisory Responsibility
N/A
Work Environment
This job operates in a professional office environment. This job can be onsite, remote, or hybrid. This role routinely uses standard office equipment such as computers, phones, and printers.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this position, the employee is regularly required to sit and use hands to finger, handle, or feel objects, tools or controls. The employee is frequently required to reach with hands and arms and talk or hear. The employee is occasionally required to walk. Specific vision abilities required by this position include close vision, color vision and the ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 4:30 p.m. Occasional early morning, evening, and weekend work may be required as job duties demand. Alternate hours can be arranged with management based on meeting schedules, etc.
Travel
Local candidates: Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected.
Remote workers: Periodic travel to Sovereign is expected for business needs – generally once or twice a year for 3-5 days per visit.
Required Education and Experience
- Bachelor’s degree in chemistry, life sciences, regulatory affairs or equivalent pharmaceutical experience.
- Three to six years of regulatory experience or equivalent quality, pharmaceutical, or life science experience.
- Experience with Microsoft Office suite and Adobe Acrobat. Experience with Adobe Illustrator a plus.
Preferred Education and Experience
- RAC certification a plus but not required.
Work Authorization/Security Clearance (if applicable)
N/A
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
About Alora Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Alpharetta, GA, US
Year founded
2011