regulatory affairs associate in maidenhead

posted
06 February 2019
contact
fiona donald, randstad business support
job type
contract
salary
Competitive
apply now

posted
location
maidenhead, south east
specialism
pharmaceutical
sub specialism
Quality
job type
contract
working hours
Full-Time
salary
Competitive
reference number
0848
contact
fiona donald, randstad business support
apply now

job description

Regulatory Affair Associate

Location: Maidenhead

Contract: 6 Months

An exciting new opportunity to work in Regulatory Affairs role in multinational biotechnology company.

Summary

Responsible for oversight of artwork updates and change management for EU marketed products. Responsible for assisting in planning and preparation of submissions to regulatory authorities.

Job Description

Regulatory Systems



* Responsible for initiating and maintaining oversight of artwork updates for EU marketed products, via emails and in relevant systems
* Point of contact with artwork team for all products, providing oversight and leading change management meetings
* Review and approval of artwork mock ups for product launches as required
* Responsible for onboarding of new EU Affiliates and Distributors
* Oversight of regulatory systems and participation on system improvement workstreams

Regulatory Support



* Responsible for assisting in the planning and preparation of regulatory submissions relevant to assigned projects or programs
* Prepare and deliver effective presentations for internal audiences
* Participate in contacts with regulatory agencies relevant to assigned projects or programs, as appropriate
* Participate in discussions regarding regulatory strategy
* Represent regulatory on relevant teams, as appropriate
* Take steps to actively improve interdepartmental communications
* Develop and write department SOPS

Qualifications



* Experience and/or knowledge of the oversight of artwork updates and change management and/or preparation of regulatory submissions
* Ability to work somewhat independently with minimal direction and within project teams
* Good communication skills
* Basic organizational skills
* Good interpersonal skills and the ability to deal effectively with a variety of personnel
* Demonstrate some cross-cultural and cross-functional awareness
* Knowledge and understanding of applicable regulations
* Computer literate
* Sensitivity for a multicultural/multinational environment

Education



* BA/BS/University degree required, Life/Health Sciences preferred

Randstad Business Support is acting as an Employment Business in relation to this vacancy.