Regulatory Compliance Specialist

Apodi Ltd
11 Jan 2018
10 Feb 2018
Contract Type
Full Time
Our client, a global pharmaceutical business is recruiting for a Regulatory Compliance Specialist to join their busy team.

Your role will be to manage the regulatory requirements from teams in Northern Europe with emphasis on the UK/IE. You will be accountable for managing the communication and reporting of competent authorities.

Your duties will include but not limited to:

* Responsible for adverse events reporting to the local competent authorities in a timely manner in UK and Ireland
* Responsible for reviewing and coordination of answers to requests of information; including the monitoring of all the requests on company system. Report on issues.
* Responsible for taking PRE-local decisions in case of incidents and to report these on the company system.
* Communication to customers, third parties and Internal support for other employees regarding regulatory compliance as needed.
* Accountable for reaching the reconciliation of the implemented Field Safety corrective actions
* in NEC and communicating regularly with the CA.
* Assist in any duty within the company as is reasonably requested

You will have previously worked in a similar role and will ideally have a Scientific/Biology/Microbiology degree. You will have managed competent authorities and will have experience in regulatory affairs and compliance. You will be working with a remote team of six and will have previously managed or arranged audits.

This role is to work on a temp to perm basis (initially 3 months) with a view to the role going permanent if successful in post. We require immediately available candidate ASAP so if you think this sounds like you then PLEASE APPLY NOW!!
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