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Regulatory Affairs 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
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At United States
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
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 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
Senior Manager Regulatory Affairs | $90,000- 140,000/Yr
By PWR Staffing & Recruiting At New York, NY, United States
Ensure claims are compliant with The Avon and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products, including OTC
Product development experience is 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
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 ...

Senior Regulatory Affairs Manager - Hybrid
By Hi-Quality Recruits At New York, NY, United States
Ensure claims are compliant with the company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC
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
Excellent organizational and analytical skills to complete assignments accurately
Senior Manager Regulatory Affairs
By Jasper Therapeutics At Redwood City, CA, United States
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Must be able to effectively identify data needs, and successfully present to management.
Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
Maintain up-to-date knowledge of current regulations for applicable territories. •
Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.
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.
Global Customer Experience Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , Westborough, Ma $106,692 - $149,366 a year
Experience and knowledge of all call center KPI & SL metrics.
Experience in driving change via business cases for transformation.
BA/BS in Business, communications. Equivalent years of experience in the business operation field and or medical device.
Experience of managing a critical path regarding customer complaints would be advantageous
Hands-on experience with service and support workflow tools such as ServiceNow, SFDC, Veeva, Oracle Zendesk.
Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.
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].
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , San Jose, 94088, Ca $115,026 - $161,036 a year
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
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.
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.

Are you looking for an exciting opportunity to use your regulatory expertise to help shape the future of healthcare? We are seeking a Regulatory Affairs Manager to join our team and help us bring innovative products to the market. In this role, you will be responsible for developing and executing regulatory strategies, managing regulatory submissions, and ensuring compliance with applicable regulations. If you are a strategic thinker with a passion for making a difference, this could be the perfect job for you!

A Regulatory Affairs Manager is responsible for ensuring that a company’s products comply with all applicable laws and regulations. This includes researching, interpreting, and implementing regulations, as well as developing and maintaining regulatory strategies.

What is Regulatory Affairs Manager Skills Required?

• Knowledge of relevant laws and regulations
• Excellent communication and organizational skills
• Ability to work independently and as part of a team
• Ability to interpret and analyze complex data
• Ability to manage multiple projects simultaneously
• Ability to work under pressure and meet deadlines

What is Regulatory Affairs Manager Qualifications?

• Bachelor’s degree in a relevant field, such as law, public policy, or regulatory affairs
• Relevant experience in regulatory affairs
• Professional certification in regulatory affairs (preferred)

What is Regulatory Affairs Manager Knowledge?

• Knowledge of relevant laws and regulations
• Knowledge of the product development process
• Knowledge of the pharmaceutical industry
• Knowledge of the medical device industry

What is Regulatory Affairs Manager Experience?

• Experience in regulatory affairs
• Experience in the pharmaceutical or medical device industry
• Experience in product development

What is Regulatory Affairs Manager Responsibilities?

• Research, interpret, and implement relevant laws and regulations
• Develop and maintain regulatory strategies
• Monitor changes in regulations and advise management accordingly
• Prepare and submit regulatory documents
•