Reference Number: JO-2308-520966
Senior Regulatory Affairs Associate
Rate: Negotiable
Job Type: Contract
Location: Reading

Senior Regulatory Affairs Associate

Maternity Cover -6- 9 month contract

Flexible working from Berkshire office

September start

Offering up to £36.00 Per Hour DOE PAYE

An innovative pharmaceutical organisation is looking for a Senior Regulatory Affairs Associate to support product Market Authorisations with the UK and Ireland affiliates on an 6-9 month maternity cover. Reporting to the Regulatory Affairs Manager you will be responsible for registrations applications to the UK and Ireland Authorities. You shall also support the launch of new products and life cycle management activities.

Job Responsibilities include;

– Prepare or manage the preparation of marketing authorisation applications under supervision, to the highest possible standards within the agreed timeframe for submitting to the regulatory authorities via national, mutual recognition, decentralised and centralised procedures. – Prepare efficiently and submit responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.

– For Centralised Applications, ensure that Global Business Units are informed of status of applications and artwork is developed to support new submissions and product launches

– Prepare and review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and take action, as agreed with supervisor, to secure regulatory approval where necessary.

Candidate Requirements include;

– Eligible to live and work in the United Kingdom

– Life Sciences degree or equivalent qualification

– 2-4 years Regulatory Affairs experience, preferably supporting the UK/IR affiliates

– Able to work from Berkshire a minimum or 2 days per week

If this opportunity is of interest to you please forward your up to date CV to Sophie on sophie.malyon@cpl.com.

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