Regulatory affairs specialist Work, Jobs in Tring, Hrt (with Salaries)

Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
Quick apply
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
Sr. Drug Safety Specialist
GE HEALTHCARE —Chalfont Saint Giles
- Microsoft Word
- Data entry
QA Specialist W&D
Medline Europe —Bicester
- Microsoft Word
- Bachelor's degree
- Continuous improvement
- Employee assistance programme
- Life insurance
Quick apply
9d
QA Specialist W&D
ASID BONZ GmbH —Bicester
- Microsoft Word
- Bachelor's degree
- Continuous improvement
- Employee assistance programme
- Life insurance
9d
Country Medical Director, UK and Ireland
Gilead Sciences —London
- Full-time
- Hybrid work
- Management
- Research
- Recruiting
12d
Solicitor Court of Protection
HAB Law —Watford
- £30,000 - £60,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Mentoring
- Communication skills
- Free parking
- Work from home
Quick apply
8d
Vice President / Associate Director, Crisis & Risk
Edelman —London
- Full-time
- Project management
- IT
Land and Property Programme Manager
East West Rail —Milton Keynes
- Hybrid work
- Team management
- Contracts
- Annual leave
- Employee assistance programme
Quick apply
13d

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Medical Device Regulatory Affairs Specialist
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Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
Support review of product ideations, raw material assessment, formulation assessment, new claims, labels, advertising materials, third party products and…
Quick apply

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Sr. Specialist, Regulatory Affairs

The Bountiful Company -
Tring

Quick apply

Job details

Permanent

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Outlook
Labelling
Computer literacy
Writing skills
Microsoft Office Suite
Analysis skills
Compliance management
Bachelor's degree
Content management
Communication skills
Analytics

Full job description

Job Description

The Senior Regulatory Affairs Specialist plays a critical role ensuring in-market regulatory compliance of new and existing products, packaging and communications. An experienced regulatory or technical professional, the Senior Specialist will have, or quickly develop, a strong understanding of applicable regulations, guidance and industry best practice pertaining to the product portfolio they support.

The individual will work independently with a high level of responsibility. In addition to label content management and formula review they will take ownership of and deliver successfully smaller projects and specific regulatory elements within larger projects.

Review, maintain and create manuscript (label content) records for The Bountiful Company's product portfolio of Dietary Supplements, Foods, OTCs and Cosmetics, as applicable, by interpreting and applying applicable regulations and guidance.
Compiles and interprets substantiation documentation for accurate and compliant labeling.
As directed, take ownership of and deliver successfully smaller projects and specific regulatory elements within larger projects such as innovation, implementation of new regulations, portfolio assessment and change control.
Support review of product ideations, raw material assessment, formulation assessment, new claims, labels, advertising materials, third party products and related brand activities
Compile dossiers to support license or registration submissions or updates ensuring compliance with regulatory requirements, as applicable
US region: Draft FDA 30 Day Notification Letters
Performs various calculations and evaluations to substantiate compliant labeling: formula, percent daily values, vitamin & mineral conversions, nutritional claim support, structure/function claims.
Develop and maintain accurate and compliant label content for portfolio dietary supplements, foods, over the counter drug and cosmetic products, as applicable.
Demonstrates high level of understanding of applicable regulations and implements.
Follows Safety, Health, and Environmental policies and procedures.
Supervises and/or trains one or more regulatory associates, as relevant and when required
Performs other duties as assigned.

Qualifications

Ideal candidate would have previous exposure to and application of regulations pertaining to dietary supplements, foods, cosmetics or OTC pharmaceutical categories, label development or a scientific/ technical background
Functional experience: 3 to 5 years of relevant prior business experience preferred. 1 to 2 years of experience in a regulatory affairs, quality or equivalent technical role preferred.
Education: Bachelor degree required.

Skills

Strong written and verbal communication skills
A self-starter with willingness to learn and develop
Demonstrates strong team work, collaboration, attention to detail, analytical skills, and organization
Basic computer skills, including Microsoft Outlook, Excel, Word, and PowerPoint

Quick apply

Refine Your Search

regulatory affairs specialist jobs in tring, hrt

Sr. Specialist, Regulatory Affairs

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Sr. Drug Safety Specialist

QA Specialist W&D

QA Specialist W&D

Country Medical Director, UK and Ireland

Solicitor Court of Protection

Vice President / Associate Director, Crisis & Risk

Land and Property Programme Manager

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