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Senior Regulatory Officer

Pharmaceutial & Biotechnolgy
Technical Specialist
Regulatory
Guildford
£45,000 - £48,000

Role Overview

This role will be responsible for the preparation, distribution and control of registration documentation required for regulatory submissions to high standards and within agreed timelines to ensure that marketing authorisations are obtained and maintained in line with the company’s requirements
The successful candidate will work proactively with team members to ensure project needs are met compliantly within agreed timelines.

Company Information

Zenopa has partnered with a leading manufacturer of generic pharmaceutical products throughout the Uk and Europe.

Role Requirements

Responsibilities:
– Preparation of marketing authorisation application documentation to the highest possible standards, within the required timeframe, for submission to the regulatory authorities.
– Whole regulatory process, submissions for new launches.
– Working with a team towards a common goal with regulatory activities, this could be MHRA handling, submissions and dealing with variations.

Person Specifications

A record of proven success in achieving regulatory approvals for marketing authorisations in the UK.
A record of proven success in leading, managing and developing staff.
Good knowledge of the development process for generic medicines, and capable of critically reviewing and integrating scientific information from a variety of disciplines.
Ability to manage multi-functional projects, and to assess detailed scientific information from a variety of disciplines.
Good organisational skills and ability to manage multiple projects/priorities under pressure and to cope with tight deadlines.

Package

Competitive Salary
Bonus Scheme
Car Allowance
Pension
Private Healthcare

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    Locations

    Aldershot
    Camberley
    Guildford
    Woking
    Date Updated
    15 Apr 2024
    Job reference
    72742
    Categories
    Full Time
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    Why Zenopa?

    We aim to operate and maintain the following set of core values

    Group people cartoon
    01
    In house, contracting department.

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    02
    We liaise on your behalf

    Required equipment, e.g. cars, laptops, mobiles, we negotiate with the employer source and manage these on your behalf.

    03
    Solid Industry Relationships

    Our recruitment teams have built relationships with some of the UK’s most prestigious pharmaceutical companies

    04
    High Success Rate

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    05
    Systems that work for you

    As an ISO 9000 organisation we have fully defined systems that are regularly audited. You can be assured we consistently following processes that deliver for all.