Overview
On Site
Full Time
Skills
Research and Development
Purchasing
Marketing
Manufacturing
Management
Regulatory Compliance
Database
Process Engineering
Regulatory Affairs
Medical Devices
Pharmaceutics
Project Management
SAP BASIS
Law
IT Service Management
Innovation
Collaboration
Recruiting
Insurance
Finance
Professional Development
Training
Leadership
CompTIA
Customer Service
Career Counseling
Apex
Oracle Application Express
Job Details
Job#: 3017564
Job Description:
Regulatory Affairs Document Specialist
Well established and growing nutraceutical company is growing their team and adding to their Regulatory Affairs department!
Summary:
The Regulatory Affairs Document Specialist provides support in various projects, including formulas, labels, product materials, and records review, product registration and help support the work associated with obtaining government approval for product imports into global markets. The key scope of this job is to deliver support in order to ensure effectiveness, efficiency, and accuracy of daily operations in Regulatory Affairs team. This position will work cross functionally with Research & Development, Purchasing, Marketing, Quality and other departments.
ESSENTIAL DUTIES/RESPONSIBILITIES/FUNCTIONS:
Creates, revises, and maintains records of US master labels and basic registration documents including but not limited to Manufacturing Process, Nutritional Information, Product Formula, Product Safety Statement, Technical Data Sheet, Technical Info on Key Ingredients.
Prepares documents, communicates, and maintains record keeping for product registration renewals for applicable countries.
Requests from suppliers and maintains up-to-date raw material documents including allergens, gluten, GMO, Kosher/Halal, etc.
Performs and manages country legalizations tasks including requesting money, contacting courier, placing request for embassy legalizations, mailing and tracking documents, etc.
Assists in the management of project timelines and provides support to project teams and Senior Management.
Reviews and ensures compliance and technical accuracy with formulation, label graphics, and ingredient claims.
Maintains accurate and up-to-date regulatory records and databases and responds to document and information requests.
Requests samples as needed.
Assists with process development.
Handles basic issues and problems and refer more complex issues to higher-level staff.
All other duties as assigned.
EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:
Minimum education: Bachelor's degree or equivalent work experience. Preferred: Bachelor of scientific or health discipline.
Minimum experience: 0-1 year of experience of Regulatory Affairs in food, dietary supplements, cosmetics, medical device, pharmaceutical or related field. Preferred: 1-2 years of experience in Regulatory Affairs in food, dietary supplements, cosmetics, medical device pharmaceutical or related field. Project Management experience.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Job Description:
Regulatory Affairs Document Specialist
Well established and growing nutraceutical company is growing their team and adding to their Regulatory Affairs department!
Summary:
The Regulatory Affairs Document Specialist provides support in various projects, including formulas, labels, product materials, and records review, product registration and help support the work associated with obtaining government approval for product imports into global markets. The key scope of this job is to deliver support in order to ensure effectiveness, efficiency, and accuracy of daily operations in Regulatory Affairs team. This position will work cross functionally with Research & Development, Purchasing, Marketing, Quality and other departments.
ESSENTIAL DUTIES/RESPONSIBILITIES/FUNCTIONS:
Creates, revises, and maintains records of US master labels and basic registration documents including but not limited to Manufacturing Process, Nutritional Information, Product Formula, Product Safety Statement, Technical Data Sheet, Technical Info on Key Ingredients.
Prepares documents, communicates, and maintains record keeping for product registration renewals for applicable countries.
Requests from suppliers and maintains up-to-date raw material documents including allergens, gluten, GMO, Kosher/Halal, etc.
Performs and manages country legalizations tasks including requesting money, contacting courier, placing request for embassy legalizations, mailing and tracking documents, etc.
Assists in the management of project timelines and provides support to project teams and Senior Management.
Reviews and ensures compliance and technical accuracy with formulation, label graphics, and ingredient claims.
Maintains accurate and up-to-date regulatory records and databases and responds to document and information requests.
Requests samples as needed.
Assists with process development.
Handles basic issues and problems and refer more complex issues to higher-level staff.
All other duties as assigned.
EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:
Minimum education: Bachelor's degree or equivalent work experience. Preferred: Bachelor of scientific or health discipline.
Minimum experience: 0-1 year of experience of Regulatory Affairs in food, dietary supplements, cosmetics, medical device, pharmaceutical or related field. Preferred: 1-2 years of experience in Regulatory Affairs in food, dietary supplements, cosmetics, medical device pharmaceutical or related field. Project Management experience.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.