Qureos Mentor

Prestige Consumer Healthcare

<p></p><div><div>Tarrytown, NY
</div><p></p><div>Full Time
</div><p></p><div>Entry Level</div></div>
<br><p>Job Title: Regulatory Affairs Labeling Coordinator
Prestige Consumer Healthcare (Prestige) is a company that focuses on product innovation and quality in the over-the-counter healthcare and women&rsquo;s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.
JOB SUMMARY
The Regulatory Affairs Label Reviewer will report to the Senior Manager, Regulatory Affairs and, under the direction and guidance of the Head of Regulatory Affairs, to ensure regulatory compliance of labeling and associated materials of Prestige marketed products. Product categories include Over the Counter (OTC_ Monograph drugs, OTC_New Drug Applications (NDAs)), Medical Devices, Cosmetics, Dietary Supplements and EPA-registered products.
Detail-oriented proofreader to perform these responsibilities including, but not limited to:
Meticulous review and approval of product labels (i.e. primary, secondary, individual folding cartons (IFCs), displays, and coupons noting errors such as punctuation and spelling and comparison to the previous version of the label and identified revisions. Utilize the in-house system to execute process and coordinate with other internal stakeholders.
Review entire content of label(s) provided by Marketing, Packaging, Legal, and Regulatory Affairs.
Proofread documents and provide feedback for various submissions and registrations, as requested
Train new employees on the in-house labeling system. Provide system support to new and current users.
Style Guides &ndash; utilize in-house guide to ensure label consistency and accuracy; maintain its accuracy and update as needed.
Keep abreast of changing requirements and monitor and elevate any deviations from requirements, regulatory developments, guidelines, and regulations.
Keep track of &amp; Expedite priority projects
EDUCATION/ CERTIFICATION:
Bachelor's Degree preferred or equivalent in relevant experience
QUALIFICATIONS:
Basic knowledge of labeling content and format for OTC drug, medical device, cosmetic and dietary supplement products
Fact-checking and research expertise
Strong written skills
Multi-tasking and prioritization skills
Excellent grammar and communication skills
Proficiency in basic computer programs (i.e. Microsoft Office, Adobe Acrobat)
REQUIREMENTS:
Experience and ability to undertake the main responsibilities of the position
2+ years of experience in proofreading preferred
Travel: none
LANGUAGE SKILLS:
Ability to read, analyze, and interpret general information and technical procedures, or governmental regulations. Ability to write succinct and clear correspondence and procedure manuals. Ability to effectively present information and respond to questions from internal stakeholders.
MATHEMATICAL SKILLS:
Ability to calculate figures and amounts such as percentages.
REASONING ABILITY:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
#HybridWork: We follow a Hybrid work schedule. All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).
Work Hours: 40 hours per week.
Salary: $48,000 to $62,000 with 5% bonus potential</p>

Regulatory Affairs Labeling Coordinator

<p></p><div><div>United States
</div><p></p><div>Full Time
</div><p></p><div>Entry Level</div></div>
<br><p>Job Title: Labeling Compliance Coordinator
Prestige Consumer Healthcare (Prestige) is a company that focuses on product innovation and quality in the over-the-counter healthcare and women&rsquo;s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.
JOB SUMMARY
The Regulatory Affairs Label Reviewer will report to the Senior Manager, Regulatory Affairs and, under the direction and guidance of the Head of Regulatory Affairs, to ensure regulatory compliance of labeling and associated materials of Prestige marketed products. Product categories include Over the Counter (OTC_ Monograph drugs, OTC_New Drug Applications (NDAs)), Medical Devices, Cosmetics, Dietary Supplements and EPA-registered products.
Detail-oriented proofreader to perform these responsibilities including, but not limited to:
Meticulous review and approval of product labels (i.e. primary, secondary, individual folding cartons (IFCs), displays, and coupons noting errors such as punctuation and spelling and comparison to the previous version of the label and identified revisions. Utilize the in-house system to execute process and coordinate with other internal stakeholders.
Review entire content of label(s) provided by Marketing, Packaging, Legal, and Regulatory Affairs.
Proofread documents and provide feedback for various submissions and registrations, as requested
Train new employees on the in-house labeling system. Provide system support to new and current users.
Style Guides &ndash; utilize in-house guide to ensure label consistency and accuracy; maintain its accuracy and update as needed.
Keep abreast of changing requirements and monitor and elevate any deviations from requirements, regulatory developments, guidelines, and regulations.
Keep track of &amp; Expedite priority projects
EDUCATION/ CERTIFICATION:
Bachelor's Degree preferred or equivalent in relevant experience
QUALIFICATIONS:
Basic knowledge of labeling content and format for OTC drug, medical device, cosmetic and dietary supplement products
Fact-checking and research expertise
Strong written skills
Multi-tasking and prioritization skills
Excellent grammar and communication skills
Proficiency in basic computer programs (i.e. Microsoft Office, Adobe Acrobat)
REQUIREMENTS:
Experience and ability to undertake the main responsibilities of the position
2+ years of experience in proofreading preferred
Travel: none
LANGUAGE SKILLS:
Ability to read, analyze, and interpret general information and technical procedures, or governmental regulations. Ability to write succinct and clear correspondence and procedure manuals. Ability to effectively present information and respond to questions from internal stakeholders.
MATHEMATICAL SKILLS:
Ability to calculate figures and amounts such as percentages.
REASONING ABILITY:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
#HybridWork: We follow a Hybrid work schedule. All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).
Work Hours: 40 hours per week.
Salary: $48,000 to $62,000 with 5% bonus potential</p>

Labeling Compliance Coordinator

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Prestige Consumer Healthcare

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Regulatory Affairs Labeling Coordinator

Labeling Compliance Coordinator