Regulatory Affairs Manager

Location: West Yorkshire  |  West Yorkshire  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHRA/Manager
Salary: £40000 - £48000
Job Status: Permanent / Full Time

I am currently looking for a Regulatory Consultant/Manager in West Yorkshire

Regulatory Consultant/Manager

I am seeking a Regulatory Consultant to contribute to regulatory and quality project teams I need someone with at least 4 years regulatory experience, with experience of medical devices industry e.g. at least an undergraduate placement year.

The role is primarily office based with travel required: approximately 5 – 10% of time

Job Duties and Responsibilities:

To contribute to regulatory and quality project teams

To review technical data as part of a project team

To provide regulatory review and technical input

To provide quality review and input

To become point of contact on medical devices information

To learn and develop skills in order to prepare and contribute to regulatory documentation (e.g., relevant sections within CTAs, MAAs, INDs and NDAs, Variations, Renewals), etc.

To comply with Woodley BioReg and clients’ Quality Standards

To continuously develop technical, interpersonal skills

To engage with the wider team and sector to gain wider knowledge of the industry, changes in legislation and working procedures affecting the environment of Woodley BioReg

Provide support to other functions with Woodley BioReg as requested

To build and maintain expertise and develop a scientific profile in appropriate scientific disciplines, through publication and attendance at relevant scientific and regulatory meetings and/or conferences.

Ad hoc activities / project work as required.

REQUIRED COMPETENCIES

Life science graduate or equivalent

4 year’s regulatory experience

Experience of medical devices industry e.g. at least an undergraduate placement year

Experience of the pharmaceutical industry would be preferable

BSc, or country equivalent, as a minimum, in a relevant life-science subject

Locally recognised professional Regulatory qualification, or working towards, e.g TOPRA in UK.

This position is offering from £40,000 up to £48,000 depending experience, it also comes with a bonus, pension and health cover.

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.