Regulatory Affairs Officer - (Pharmaceutical)

Contract:
Permanent
Category:
Full Time
Job Sector:
Nursing / Social Care
Region:
South Wales
Location:
Cardiff
Salary description:
£30000 - £33000/ annum Excellent Benefits
Posted:
30/07/2019
Start Date:
ASAP
Recruiter:
Anonymous
Job Ref:
739158960

Company Description

REED Scientific have an exciting opportunity for a Regulatory Affairs Officer to work for a customised enzyme discovery, development and manufacturing company based in the UK. We work with our customers, many of which are the top blue-chip companies, to provide unique enzyme solutions that help them solve process problems, valorise waste, facilitate biochemical reactions or deliver competitive advantage through using a unique product.

Requirements

Purpose of the role

To lead and coordinate the regulatory approval submissions for new enzymes.
To provide support for regulatory matters to ensure compliance with current and future enzyme regulations for industry sectors and primary geographical markets.Key result areas

On time product launches through timely submission of regulatory approvals for new enzymes as specified in project plans.
On time responses to customer regulatory enquiries as specified in Service Level Agreements.Need to know

Degree in Science, Regulatory Affairs or equivalent.
Knowledge of regulatory affairs in a food, pharma or biotechnology environment.Need to be able to do: (Key activities)

Prepare and deliver technical reports and information reports including new product regulatory submissions.
Effective and efficient communication with external stakeholders including consultants and regulatory bodies.
Carry out the responsibilities stated in the Managing Directors Health & Safety Policy detailed in paragraphs 9 and 10 of his management Directive.
Be conversant with and adopt the procedures stated in the Environmental Management System (EMS) Manual and its supporting documents.Expected behaviour

Analytical thinking.
Ability to learn.
Planning & Organisation.
Results driven.
Team Work.
Communication.Qualifications, Experience & Skills

Degree (or equivalent) in Science, Regulatory Affairs or equivalent.
Handling in-bound Regulatory & Product related Customer enquiries in a professional manner.
Completion of Customer Regulatory & Food safety questionnaires.
Completing submissions to regulatory bodies.
Administration skills.
Working in a Regulatory Affairs or Quality Assurance environment.
Regulatory Affairs and procedures.
Food safety, HACCP and GMP.
Food / Biotech / Biosciences / Pharma Industry.
Global food legislation.
High Quality Work on Time - The focus on delivering quality and continuous improvement in a timely fashion.
Planning & Organising - The ability to decide on courses of action, ensuring that the resources required to implement the action will be available and scheduling the programme of work required to achieve a defined end-result.
Analytical Thinking - The capacity to analyse situations, diagnose problems, identify the key issues, establish and evaluate alternative courses of action and produce a logical, practical and acceptable solution.
Communication - the ability to communicate clearly and persuasively, orally or in writing.
Decision Making & Knowledge - The capacity to make sound and practical decisions which deal effectively with the issues and are based on thorough analysis and diagnosis.
Proactive and Driven.
Willingness to learn.
Positive and friendly attitude to dealing with people.
High attention to detail, systematic and thorough.Ability to multi task and work under pressure to meet strict deadlines

Company Description

Closing Date:
27/08/2019

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