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Senior Regulatory Affairs Manager Jobs

Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
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 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.
Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
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].
Director/Senior Director Regulatory Affairs
By RBW Consulting At United States
7-10+ years Regulatory Affairs experience
Experience in development and commercial product lifecycle (Phases 1-3, Marketed Products)
Relevant experience with regulatory applications (IND / CTA / NDA / MAA etc.)
Success in filing IND's/CTA's in Oncology
Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.
Direct exposure to FDA/EMA etc. Interactions
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
Senior Manager, Corporate Affairs Bpo
By Visa At San Francisco, CA, United States
Proven business operations and/or project/program management skills, highly organized, with experience of exercising informal authority in cross functional team settings
Strong written and verbal communication skills with storytelling orientation
Senior Manager, Corporate Affairs BPO
Deliver ongoing reporting against performance milestones and metrics, and organize critical information, issues, and data across teams to facilitate efficient decision-making
Develop content and presentations for key internal and external meetings (including Board materials and business reviews)
Identify process gaps or improvements and design and implement solutions to improve the productivity of the overall organization
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.

Are you an experienced Regulatory Affairs Manager looking for a new challenge? We are seeking a Senior Regulatory Affairs Manager to join our team and help us develop and implement regulatory strategies to ensure compliance with global regulatory requirements. You will have the opportunity to work with a dynamic team of professionals and make a real impact on the success of our organization. If you are looking for an exciting and rewarding career, this is the job for you!

Overview:

A Senior Regulatory Affairs Manager is responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They are responsible for developing, implementing, and maintaining regulatory strategies and processes, as well as providing guidance and advice to other departments. They must also stay up to date on changes in the regulatory environment and ensure that the company is in compliance.

How To Become an Senior Regulatory Affairs Manager:

To become a Senior Regulatory Affairs Manager, you typically need a combination of education and experience. Most employers require a bachelor’s degree in a related field, such as biology, chemistry, or engineering. Additionally, many employers prefer candidates with a master’s degree in a related field. Experience in regulatory affairs is also beneficial.

Senior Regulatory Affairs Manager Skills:

• Knowledge of applicable laws and regulations
• Ability to develop and implement regulatory strategies
• Excellent communication and interpersonal skills
• Strong organizational and problem-solving skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite

What is Senior Regulatory Affairs Manager Knowledge?

• Knowledge of applicable laws and regulations
• Understanding of the regulatory environment
• Knowledge of regulatory processes and procedures
• Knowledge of product development and manufacturing processes
• Knowledge of quality assurance and control

What is Senior Regulatory Affairs Manager Responsibilities?

• Develop, implement, and maintain regulatory strategies and processes
• Monitor changes in the regulatory environment and ensure compliance
• Provide guidance and advice to other departments
• Prepare and submit regulatory documents and applications
• Liaise with regulatory authorities
• Monitor and review product labeling and advertising
• Ensure compliance with applicable laws and regulations

What is Senior Regulatory Affairs Manager Experience?

• Experience in regulatory affairs
• Experience in product development and manufacturing processes
• Experience in quality assurance and control
• Experience in preparing and submitting regulatory documents and applications
• Experience in liaising with regulatory authorities
• Experience in monitoring and reviewing product labeling and advertising

What is Senior Regulatory Affairs Manager Qualifications?

• Bachelor’s degree in a related field, such as biology, chemistry, or engineering
• Master’s degree in a related field (preferred)
• Relevant certifications (preferred)

Senior Regulatory Affairs Manager Education:

• Bachelor’s degree in a related field, such as biology, chemistry, or engineering
• Master’s degree in a related field (preferred)
• Relevant certifications (preferred)

Tools to Help Senior Regulatory Affairs Manager Work Better:

• Regulatory tracking software
• Document management systems
• Quality management systems
• Regulatory databases
• Compliance management systems

Good Tips to Help Senior Regulatory Affairs Manager Do More Effectively:

• Stay up to date on changes in the regulatory environment
• Develop and maintain strong relationships with regulatory authorities
• Develop and implement effective regulatory strategies
• Monitor and review product labeling and advertising
• Ensure compliance with applicable laws and regulations

Common Senior Regulatory Affairs Manager Interview Questions:

• What experience do you have in regulatory affairs?
• How do you stay up to date on changes in the regulatory environment?
• What strategies have you implemented to ensure compliance with applicable laws and regulations?
• How do you ensure that product labeling and advertising are compliant?
• What challenges have you faced in regulatory affairs and how did you address them?