Overview
Reference Number: JO-2311-525648
Regulatory Affairs Consultant
Rate: Negotiable
Job Type: Contract
Location: Basingstoke
Regulatory Affairs Consultant
12 month contract
3 days per week, office based Hampshire
Offering up to £60.00 Per Hour via PAYE
UK/Malta Focus
A Regulatory opportunity has arisen with leading Pharmaceutical organisation who produce over … innovative medicines to patients across the UK and globally. Working as a interim Head of Regulatory/Regulatory Consultant on an initial 12 month contract basis you will be responsible for leading all aspects of Regulatory Affairs across their UK and Malta product portfolio. Reporting into the Associate Vice President, this individual will be a leading the Regulatory group on successful new product registration, new indications and providing operational regulatory expertise.
Role Responsibilities include;
– Develop and implement the regulatory plan and strategy in alignment with affiliate business plans as well as regulatory requirements.
– Preparation and support of new applications to obtain marketing authorisations.
– Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan
– Manage and support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel
– Ensure adherence with global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labeling
Candidate requirements include;
– Eligibility to live and work in the United Kingdom
– Life Sciences degree or equivalent academic background
– Extensive experience leading regulatory affairs projects in the UK affiliate
– Excellent communication, problem solving, and interpersonal skills.
If this opportunity is of interest to yourself, please forward your up to date CV to sophie.malyon@cpl.com.
