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Regulatory Affairs Labeling Manager Jobs

Regulatory Affairs Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Regulatory Affairs Manager Jobs
By Brunel At Dallas-Fort Worth Metroplex, United States
5+ years of progressive regualtory affairs experience
Submissions experience - EU and International markets
Oversee the regualtory function for full product portfolio, managing a team, department and budget
Coordinate regulatory submissions in US and OUS markets
Provide regulatory input/support for audits
Regulatory strategy for product development
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
Regulatory Affairs Manager Jobs
By DHL At , Westerville, 43082
Presentation and project management skills
Experience with regulatory licensing, regulatory agencies and quality management/systems, practical application a plus
Advisor to Senior Management and Customers on regulatory issues/initiatives, including problem-solving, business pursuits, strategic direction, and significant issues.
Verify and analyze regulatory metrics and create executive management reporting
Coaching support for site management
Experience and working knowledge of Quality Assurance principles and methodology
Regulatory Affairs Program Manager, Us
By ZEISS Group At Dublin, CA, United States

The Regulatory Affairs Program Manager US is responsible for developing and monitoring regulatory submission timelines for a variety of US medical device submissions (such as 510(k)s, IDEs and/or ...

Labeling Manager Jobs
By Edwards Lifesciences At , Irvine, 92614 $106,000 - $151,000 a year
Proven successful project management leadership skills
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Develop team members to increase business acumen and functional skills.
Bachelor's Degree and related Labeling experience
Master's Degree and 6-8 years of related Labeling experience
Experience working in medical device, pharmaceutical or FDA regulated industry
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;
Regulatory Affairs Manager Jobs
By Keystone Industries At Gibbstown, NJ, United States
Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Quality Management Systems (QMS).
Collaborate with QA to ensure the quality management system (QMS) complies with relevant regulations and standards.
Oversees the implementation of risk management processes. Work with cross-functional teams to identify and address potential risks associated with regulated products.
Assesses the impact of regulatory changes on the company's products and processes and ensures compliance with these requirements.
Advise project teams on premarket regulatory requirements.
Advise on export and labeling requirements.
Regulatory Affairs Manager Jobs
By Roche At , Carlsbad, 92008
Analyzes, monitors and provides trending of Recall and Adverse Event Reporting data for Quality Management Review Meeting (QMR).
Other duties as assigned by management.
Experience with Microsoft and Google based applications and general knowledge of PC functions necessary
Experience developing field action processes complaint with global regulatory requirements
Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.•
5 years of Regulatory Affairs experience. Specific experience with IVD device experience is preferred.
Regulatory Affairs Manager Jobs
By Kelly At Kansas City Metropolitan Area, United States
Prepare regulatory assessments for project teams, line management, and key stakeholders as requested. Includes support for due diligence evaluations.
Degree(s) in a relevant scientific field (BS/MS/Ph.D.) from an accredited institution with appropriate certification in Regulatory Affairs.
High-level knowledge of registration dossier preparation for US FDA/CVM. Including development, drawing conclusions, and the effect of changes.
Proactively monitor, evaluate, and communicate existing and new US regulations impacting products and projects. Assess the potential impact and/or opportunities.
Interface with regulatory authorities on new product development and registration programs, as well as industry associations.
Coordinate technical input for preparation/review of FOI summary and label language for assigned projects.
Regulatory Affairs Manager ( Registered Nurse)
By University of Washington At , Seattle, 98195, Wa $9,000 - $12,840 a month
$ 9,000 - $12,840 per month
Who we are looking for a leader who understands:
This position serves as an expert resource and partner on:
Some of what you will do:
To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [email protected].
Regulatory Affairs Manager Jobs
By DHL At Westerville, OH, United States
Presentation and project management skills
Experience with regulatory licensing, regulatory agencies and quality management/systems, practical application a plus
Advisor to Senior Management and Customers on regulatory issues/initiatives, including problem-solving, business pursuits, strategic direction, and significant issues.
Verify and analyze regulatory metrics and create executive management reporting
Coaching support for site management
Experience and working knowledge of Quality Assurance principles and methodology
Regulatory Affairs Manager Jobs
By USK Technologies At New York City Metropolitan Area, United States
You will report to the Senior Manager, Quality, Safety and Regulatory Affairs.
Product development experience strongly preferred
Skin and personal care including OTC claim review experience strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers including verbal presentations
Manager Global Regulatory Affairs
By The Fountain Group At United States
Expert knowledge of regulations, and experience with interpretation and application
Strong negotiation skills and significant experience in interacting with regulatory authorities
Experience in the development and implementation of CMC regulatory strategies throughout the lifecycle of pharmaceuticals/devices
Experience in a pharmaceutical manufacturing facility/development laboratory preferred.
Exp withGlobal responsibility for regulatory submissions and registrations preferred
Risk identification in terms of CMC regulatory strategy
Manager Of Regulatory Affairs
By Connect Life Sciences At Washington DC-Baltimore Area, United States
Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Provides regulatory and project management support for projects as needed.
Superior organizational skills and customer service abilities.
Strong working knowledge of Microsoft office; experience with SharePoint a plus.
Supervises and manage Regulatory Team staff members, as assigned.
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.
Manager/Senior Manager Regulatory Affairs
By RBW Consulting At United States
Knowledge/experience with regulatory requirements for other regions is desirable.
Independently plan and manage regulatory activities related to assigned projects, covering areas such as clinical, non-clinical, and CMC, with minimal supervision.
Manage the preparation, review, and timely submission of regulatory dossiers required for investigation and registration of products in relevant markets.
BA/BS degree or equivalent experience in a pharmaceutical or health science field is required.
Minimum of 7 years of related experience in regulatory affairs is required.
Familiarity with CTD/eCTD and experience in publishing documents using Adobe Acrobat Professional.
Regulatory Affairs Manager Jobs
By Mira At Washington, United States
Ensure all regulatory requirements are met throughout the product development lifecycle
Review advertising and marketing materials, ensure appropriateness and compliance to FDA regulatory requirements
Maintaining current knowledge of FDA and international regulation and standards, as applicable to company products
Experience in 510k submission and MDR cases is required
Should have experience in working with startups
Strong analytical and strategic skills are required
Regulatory Affairs Manager Jobs
By Ardelyx, Inc. At Fremont, CA, United States
Develop and maintain knowledge of regulatory requirements and industry trends independently and with line manager.
Ability to interpret and understand regulatory and cGXP requirements and apply to regulatory submissions and job duties.
Experience in FDA CMC submissions utilizing eCTD format and electronic submissions.
Proficient in Microsoft Suite products, experience with VEEVA RIM preferred.
Ability to independently manage timelines in a project team environment.
Maintain awareness of and expertise in FDA and ICH guidelines related to regulatory topics.