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Associate Regulatory Affairs Specialist 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 Associate Jobs
By Agilent Technologies At California, United States
Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Maintain and updates information about global regulatory requirements.
4+ years of Regulatory Affairs experience
Post-graduate and/or certification/ license may be required.
Review product labeling and marketing materials for accuracy and compliance with regulations.
Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global At New York, NY, United States
-knowledge and experience in the insurance sector
-prior experience as an insurance supervisor
-prior experience as an actuary, insurance contract lawyer, or consultant in the financial services
-prior experience in coordinating projects involving a wide array of stakeholders.
-prior experience on ESG or cyber matters.
-ability to navigate and understand prudential regulation and supervisory guidance applicable to the insurance sector
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121 $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Regulatory Affairs Intelligence Specialist
By Abbott Laboratories At , Plymouth $56,700 - $113,300 a year
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Experience in program management a plus
Experience with document management systems a plus
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned
Strong verbal and written communication skills · Strong attention to detail and organizational skills
Regulatory Affairs Specialist Cmc
By Viatris At United States
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
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 Specialist Jobs
By ICON At , Farmingdale, 11735
Experience in regulatory requirements in clinical phase of biologics drug development is a plus
Excellent written and oral communication skills
Strong technical writing and editing skills
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
Initiate regulatory submission when required and support ICON team with Regulatory Inspections
Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
Regulatory Affairs Associate Jobs
By Earth Animal At Southport, CT, United States
Identify claims issues and lead/offer alternatives to comply with regulatory guidelines while supporting business needs.
Must be a solution oriented, self-starter with demonstrated problem solving skills.
Skilled in Excel and demonstrate accuracy with collecting and analyzing data.
Responsibilities include but are not limited to:
Lead regulatory functions and collaborate with cross-functional partners in support of the marketing review and documentation proofing process.
Regulatory Claim Subject Matter Expert (Marketing Support and Review)
Regulatory Affairs Associate Jobs
By Aditi Consulting At Plainsboro, NJ, United States
Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.
Reports to labeling management in Regulatory Operations and Innovation.
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
May be responsible for managing projects, processes, or programs with manager oversight.
Experience and/or Familiarity with Structured Content is preferred
Excellent verbal and written communication and skills.
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Des Plaines $71,300 - $142,700 a year
Interpret and apply regulatory requirements
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Principles and requirements of promotion, advertising and labeling
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Regulatory Affairs Specialist Jobs
By Philips At , Cambridge
Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations.
Experience with Software Medical Devices strongly preferred.
Proficient computer skills in Microsoft Office Suite
Read more about our employee benefits.
Specialist, Regulatory Affairs Jobs
By Edwards Lifesciences At ,
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge of new product development systems
Ability to manage competing priorities in a fast paced environment
Regulatory Affairs Specialist Cmc
By Viatris At , Remote $41,000 - $93,000 a year
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Associate Iii, Regulatory Affairs
By Sandoz At , Princeton $97,600 - $146,400 a year
Effectively monitor and track information and requirement changes
Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.
Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals
Excellent oral and written communication skills
Pharmaceutical or generic drug experience in a regulatory capacity
Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)
Regulatory Affairs Specialist Jobs
By Verathon At , Bothell $89,500 - $138,600 a year
Manage regulatory release authorization process
Experience working in an FDA regulated company for medical device or pharma is preferred
2+ years’ experience in quality assurance or regulatory affairs is preferred
Previous experience in a position that required multi-department interactions
Able to manage time effectively
Develop and compile documentation in support of new registrations
Regulatory Affairs Specialist Jobs
By Medtronic At , Woburn
Assist in keeping company informed of regulatory requirements in the International Regions.
Host meetings with relevant R&D, Quality, Manufacturing facility, Marketing and Cross Functional Teams as needed to support global registration requirements.
Bachelor's degree with 2 years of regulatory affairs experience
An advanced degree with 0 years of regulatory affairs experience
3+ years of medical device regulatory affairs experience
Experience with international submissions and experience with the FDA
Regulatory Affairs Associate Jobs
By Fred Hutchinson Cancer Center At , Seattle, 98109 $70,817 - $106,225 a year
Skilled in the use of clinical trials and electronic document management systems
Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
Assist with sponsor monitoring visits remotely and onsite as needed.
Perform other responsibilities as assigned.
Bachelor’s Degree in a related field or equivalent experience
Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)