Regulatory affairs Work, Jobs in Dunstable (with Salaries)

Sr. Specialist, Regulatory Affairs
The Bountiful Company —Tring
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Regulatory Affairs Manager UK&I
Medtronic —Watford
- £71,760 - £107,640 a year
- Full-time
- Analysis skills
- Project management
- Organisational skills
Regulatory Manager
Medik8 —Aylesbury
- £50,000 - £60,000 a year
- Hybrid work
- Management
- Leadership
- Communication skills
- Employee discount
Quick apply
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
3d
Director, Regulatory Affairs, Europe
GE HEALTHCARE —Chalfont Saint Giles
- Engineering
- Master's degree
- Bachelor's degree
Regulatory Affairs Intern
GE HEALTHCARE —Chalfont Saint Giles
- Bachelor's degree
- Internship
4d
Exec Director, Regulatory Affairs
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
Medical Science Liaison
Merz Aesthetics GmbH —Hemel Hempstead
- Nursing
- Microsoft Office
- Driving
Quick apply
11d
Vice President, Regulatory Affairs – ELMAC
Amgen —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Regeneron —Uxbridge
- Bachelor's degree
- IT
- In-person
- Annual leave
Director, Digitized Case Processing & Device Vigilance
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Oracle
- Management
- Doctoral degree
Compliance and Risk Manager
ExpandJO Business Solutions Ltd. —Watford
- £7,600 - £8,333 a month
- Full-time
- Analysis skills
- In-person
Quick apply
Executive Director, Worldwide Operations Office - Pharmacovigilance
Regeneron —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
- Annual leave
Corporate Public Affairs Lead
Roche —Welwyn
- Project management
- Communication skills
Senior Manager, Aggregate Reporting Management
Regeneron —Uxbridge
- PMP
- Analysis skills
- Project management
- Annual leave
Director Safety Surveillance & Risk Management (12 months fix term contract)
Viatris —Hatfield
- Full-time
- Hybrid work
- Bachelor's degree
- Time management
- Health & wellbeing programme
- Employee assistance programme
Executive Director, Global Patient Safety Sciences Delivery
Regeneron —Uxbridge
- Management
- Doctoral degree
- Master's degree
- Annual leave
Therapeutic Area Head, Psychiatry & Neuroscience Portfolio
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Travel
- In-person
Vice President / Associate Director, Crisis & Risk
Edelman —London
- Full-time
- Project management
- IT
6d
Medical Advisor
Norgine —Uxbridge
- Full-time
- Hybrid work
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 Excel
Microsoft Outlook
Analysis skills
Bachelor's degree
Computer skills
Communication skills

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 jobs in dunstable

Sr. Specialist, Regulatory Affairs

Regulatory Affairs Manager UK&I

Regulatory Manager

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Director, Regulatory Affairs, Europe

Regulatory Affairs Intern

Exec Director, Regulatory Affairs

Medical Science Liaison

Vice President, Regulatory Affairs – ELMAC

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Director, Digitized Case Processing & Device Vigilance

Compliance and Risk Manager

Executive Director, Worldwide Operations Office - Pharmacovigilance

Corporate Public Affairs Lead

Senior Manager, Aggregate Reporting Management

Director Safety Surveillance & Risk Management (12 months fix term contract)

Executive Director, Global Patient Safety Sciences Delivery

Therapeutic Area Head, Psychiatry & Neuroscience Portfolio

Vice President / Associate Director, Crisis & Risk

Medical Advisor

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