Regulatory Affairs Associate
Aditi Consulting, Plainsboro, NJ, United States
Payrate:
$54.64 - $54.64/hr.
Summary We are seeking a dynamic and experienced professional to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects. This role involves collaboration with cross‑functional teams, including Regulatory Affairs Therapeutic Area Managers, Global HQ, Labeling Projects and Planning Coordinators, Graphic Designers, Marketing, and Supply Chain. The ideal candidate will ensure compliance with FDA regulations and industry trends, contributing to successful project outcomes.
Responsibilities
Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements.
Identify labeling issues, troubleshoot, and communicate effectively with stakeholders to ensure timely resolution.
Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices.
Assist in the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on‑time launch of product labeling per company launch readiness timelines.
Ensure additional filing requirements are completed for approved labeling content to include SPL Drug Listing, FDA 2253s, and Puerto Rico Registrations.
Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and highly proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc.
Utilize FDA portals and tools to include ESG NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinate with internal groups and external agencies to resolve any issues.
Participate in cross‑functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity.
Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations.
Qualifications
Bachelor's degree preferred and minimum 3 years of progressively responsible experience in a pharmaceutical, biotechnology, or related environment OR equivalent combination of experience and education with a concentration in labeling development and maintenance.
3-5 years of proven experience supporting processes on brand (not generics).
Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information (SRPI), FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry‑standard labeling trends, DUNS, and FEI Registrations.
Desired Skills
Excellent communication, collaboration, and interpersonal skills to work effectively with cross‑functional teams and key company personnel.
Strong problem‑solving abilities with keen attention to detail and adherence to federal requirements and best practices.
Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.
Pay Transparency • The typical base pay for this role across the U.S. is:
$54.64 - $54.64/hr. • Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. • Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. • Full‑time employees are eligible to select from different benefits packages. • Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. • Sick leave and mobile phone reimbursement provided based on state or local law.
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$54.64 - $54.64/hr.
Summary We are seeking a dynamic and experienced professional to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects. This role involves collaboration with cross‑functional teams, including Regulatory Affairs Therapeutic Area Managers, Global HQ, Labeling Projects and Planning Coordinators, Graphic Designers, Marketing, and Supply Chain. The ideal candidate will ensure compliance with FDA regulations and industry trends, contributing to successful project outcomes.
Responsibilities
Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements.
Identify labeling issues, troubleshoot, and communicate effectively with stakeholders to ensure timely resolution.
Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices.
Assist in the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on‑time launch of product labeling per company launch readiness timelines.
Ensure additional filing requirements are completed for approved labeling content to include SPL Drug Listing, FDA 2253s, and Puerto Rico Registrations.
Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and highly proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc.
Utilize FDA portals and tools to include ESG NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinate with internal groups and external agencies to resolve any issues.
Participate in cross‑functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity.
Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations.
Qualifications
Bachelor's degree preferred and minimum 3 years of progressively responsible experience in a pharmaceutical, biotechnology, or related environment OR equivalent combination of experience and education with a concentration in labeling development and maintenance.
3-5 years of proven experience supporting processes on brand (not generics).
Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information (SRPI), FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry‑standard labeling trends, DUNS, and FEI Registrations.
Desired Skills
Excellent communication, collaboration, and interpersonal skills to work effectively with cross‑functional teams and key company personnel.
Strong problem‑solving abilities with keen attention to detail and adherence to federal requirements and best practices.
Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.
Pay Transparency • The typical base pay for this role across the U.S. is:
$54.64 - $54.64/hr. • Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. • Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. • Full‑time employees are eligible to select from different benefits packages. • Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. • Sick leave and mobile phone reimbursement provided based on state or local law.
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