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Regulatory Labeling Specialist Jobs in Fremont, Iowa

Senior Specialist, Regulatory Labeling
By Viatris At , Remote $55,000 - $105,000 a year
Conduct high level proof-reading capabilities.
Maintain current knowledge of U.S. FDA submission standards.
Normal office situation or remote.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Manager/Senior Manager Regulatory Labeling
By Karyopharm Therapeutics Inc. At , Remote $87,000 - $214,000 a year
Follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.
Manages compounds with a high degree of complexity from a labeling perspective.
Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.
5+ years of experience in global and/or local regulatory labeling within the pharmaceutical industry.
Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
Technical Writer/Labeling Specialist
By USDM Life Sciences At , Remote
Knowledge of Agile Software Document Management Solution.
Good analytical and problem-solving skills
Strong written and oral communication skills
Working on Service manuals, IFUs, knowledge of medical symbols
Basic knowledge of QSR/GMP (preferred).
Basic experience w/ print publishing, design, or document control programs.
Regulatory Affairs Labeling Manager
By Endo International At , Remote

See job description for P3003875 Regulatory Affairs Labeling Manager

Global Regulatory Lead & Head Of Regulatory Labeling
By Karyopharm Therapeutics Inc. At , Remote $175,000 - $300,000 a year
Knowledge of global regulatory requirements
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements
Minimum 10+ years’ regulatory strategy background with experience in the MDS, AML, or MM space
Preferences include recent successful NDA experience, as well as experience within a matrix environment
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
Senior Regulatory Labeling Manager
By ICON At , Remote
Excellent project management, and critical thinking skills
Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions
10+ years of relevant experience
Advanced knowledge of the scientific principles of the drug development process
Advanced, broad knowledge of regulations pertaining to drug product labeling
Excellent oral and written and written communication skills
Senior Regulatory Specialist Jobs
By Compliance Group Inc At Greater Columbus Area, United States
Applies regulatory and technical knowledge to a wide variety of complex work assignments.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
Knowledge of regulations and standards affecting IVDs and/or biologics
Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.
Provides consultation/advice to regulatory specialist for change control and product development.
Regulatory Specialist Jobs
By Barentz At North Kingstown, RI, United States
Work in close collaboration with our corporate regulatory, commercial, operations, and purchasing teams to comply with OSHA requirements
Assist in the implementation and continuous improvement of Responsible Distribution certification, including training, internal audits, and certification audits.
Other duties and responsibilities as requested
Previous experience (3+ years) in a regulatory/compliance role considered a plus
Strong problem solving, organizational skills, attention to detail, and communication skills
Strong interpersonal skills and ability to communicate effectively throughout the organization
Regulatory Labeling Manager (Us-Remote)
By Amgen At , Los Angeles $95,277 - $134,309 a year
Project Management experience, experience managing individual and group projects of moderate complexity
Experience working in a Documentum-based document management system
Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone
Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
Manages the review and approval of core DHCP letters
Food Labeling & Compliance Specialist
By Congo Brands At United States
Provide additional support for certification programs
Education: Bachelor’s degree in Food Science, Chemistry, Biology, or related fields
Experience: Minimum 1 year of responsibility in food or supplement industry and/or supplemental regulatory role
Knowledge of regulatory affairs, quality documentation, and business processes (stage gates)
Excellent communication skills, both written and oral
Experience with ESHA Genesis is preferred but not required
Senior Specialist Packaging And Labeling (Contract)
By Vertex Pharmaceuticals At , $65 - $75 an hour
The responsibilities of this position may include, but are not limited to, the following:
Master and Executed Batch Record review and resolution of comments/issues
Archiving of batch documents in electronic document system
Track data for the purpose of metrics generation
Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
Disposition Decision and status change in Oracle
Labeling Specialist, Jobs
By Gowan USA At , Yuma, Az
Experience in the ag-chem or other chemical industry helpful to understand the critical nature of labeling accuracy and requirements.
This position does not require creativity design experience. It requires more attention to details and organizational skills.
Attention to detail skills a must!
Ability to learn new technology applications. Adobe Creative Suite (InDesign, Illustrator) knowledge a plus.
Clerical and critical thinking skills.
Creates California Printer’s Proofs for Regulatory Specialists submissions.
Remote Food Safety Labeling Specialist ($30.00 - $37.00 / Hour)
By Talentify.io At United States
Strong computer skills and technical troubleshooting abilities
Work remotely from the comfort of your own home
Answer complex inbound account inquiries and provide advanced knowledge of Visa, Retail, Debit, Loyalty Program, and Gift Card products
1+ years of customer service experience
Excellent communication skills, both verbal and written
Ability to handle a high volume of calls with accuracy and deliver excellent customer experiences
Cad Labeling Specialist Jobs
By Tata Elxsi At California, United States
· “From -> To” redline creatio
The ideal support should cover these bases:-
· Onsite availability would be a nice to have for better collaboration when needed
The CAD/drawing work itself includes:-
· Conversion of critical dimension callouts to a new convention
Regulatory Labeling Specialist Jobs
By Exactech At Gainesville, FL, United States
Functional/Technical Knowledge, Skills and Abilities
Commitment to learn and stay abreast of global medical devices regulatory requirements.
Minimum 7 years' experience in related work experience
Experience with regulatory documentation is preferred
Excellent communication and interpersonal skills
Serve as company-wide labeling SME working with various workstreams to maintain compliant labeling needs.
Data Labeling Specialist (Language Quality Audit))
By Facebook At New York, NY, United States
Implement pre-approved changes to workflows and knowledge repositories.
Excellent writing and communication skills
Linguistic skills including morphology and syntax (correct grammatical, spelling, typographical, or compositional errors)
Excellent organizational skills with attention to detail
Excellent technical and computer skills
This contractor position will be responsible for the following:
Remote Regulatory Specialist ($28.00 - $31.25 / Hour)
By Talentify.io At United States
Bachelor's Degree and 3-5 years of relevant experience or equivalent combination of education and experience.
Knowledge and experience with FDA Clinical Trial regulations and guidance.
3 years of relevant experience in an academic regulatory environment.
Experience with IND/IDE/Clinical Trial Application.
Process initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Board (IRB).
Prepare and process regulatory documentation through IRB, CTSRMC, FDA, and other regulatory review committees.
Pharmaceutical Labeling Specialist - Remote
By Synectics Inc. At United States
US military experience will be considered towards industry experience requirements.
Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.
Maintains an understanding of regulatory labeling requirements of assigned region or countries.
Must possess an excellent command of language (English) and professional knowledge of medical terms,
Experience working on multi-disciplinary teams and projects
Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)
Regulatory Specialist Jobs
By Top Quality Recruitment (TQR) At Dallas, TX, United States
Complete all other duties as assigned by management.
Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.
Research of International, Federal, State, local, and internal regulatory requirements
Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.
Assisting with obtaining, and/or renewing relevant national certifications.
Work closely with the Quality Manager and Product Development teams to ensure compliance.
Senior Regulatory Specialist Jobs
By Storm4 At United States
3+ years of experience working in agricultural biotechnology and/or phytosanitary regulatory or similar
BS in biology, crop science, plant pathology, agricultural business, or related field, graduate degree preferred, or equivalent experience
Knowledge of APHIS administrative procedures and regulations
Experience interacting with state, federal, or international regulators (preferred)
Comprehensive Benefits Plan, including Medical, Dental, Vision, HSA/FSA, 401k, Life Insurance, Short-Term & Long-Term Disability, and more!
🌎 Location: U.S Remote (Some Travel)
Regulatory Specialist Jobs
By Eliassen Group At United States

Years of regulatory specialist experience in a clinical trial environment (ie premarket)

One or more of the Regulatory Certifications- AAAHRP, SOCRA, PRIM&R and similar organizations. GCP training and/or certification