Regulatory Affairs Associate

SRG

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Job ID :

4400


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,South East,Ruislip,


Key Skills :

Regulatory affairs, entry level , graduate


Salary :

£16000.00 - £18000.00 per annum


Date Posted :

10 Oct, 2016



Company Name :

SRG


Location1 :

Ruislip




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Regulatory Affairs Associate



* Our client is now looking to recruit for ambitious trainee who is interested in kick starting their career in a fast-moving company. You will undergo training aimed at giving you understanding of our business whilst gaining industry experience. It is also structured to give you the support, guidance and solid professional platform necessary to be able to find the right path, along which to take your first steps into a future career with the client.



PRIMARY RESPONSIBILITIES

* Responsible for coordinating with various departments for documentation required for submission, ensuring the documentation is of high quality and can be submitted to Health Authority.
* Review scientific literature to ensure the documentation written is of high standards for submission.



SECONDARY RESPONSIBILITIES

Regulatory Affairs



* Review of Product Information for submission to health authorities
* Responsible for reviewing literature and ensuring the prepared documentation are of high quality
* Supporting the team with review and coordination of submissions to the Health Authority
* To support the review of clinical and non-clinical sections of the dossier
* Responsible for planning the workload for defined product responsibilities in consultation with their Manager
* Keep up-to-date with Regulatory guidelines and reviewing the impact this will have on products
* Responsible for responding to regulatory queries and proactively troubleshooting technical/quality issues relating to preparations and submissions
* Supporting the Assistant Manager, Medical Affairs and Pharmacovigilance in daily activities which are required for business
* To ensure submissions of licence variations and renewals to strict deadlines
* Follow up with regulatory authorities on submissions and regulatory issues
* Assist with medical information and pharmacovigilance queries.
* Other duties to meet business needs
* Any other ad hoc duties as and when required





* ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES



* MSc/BSc Pharmacology / Pharmacy / Biomedical or Life Sciences or equivalent
* Good knowledge of ICH Guidelines and EMA guidelines
* Ability to prepare high quality regulatory applications and the ability to communicate effectively
* Ability to handle multiple tasks in a fast-paced and constantly changing environment
* Clear verbal and written communication skills is essential
* High attention to detail
* Ability to work on own initiative and in a team
* Experience of working on Microsoft

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.


Company Name:

SRG


Headquarters:

9 Devonshire Square,


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC2M 4H


Website:

www.srg.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

+44 (0) 203 096 47 0


For more information,visit www.srg.co.uk.

View all SRG Jobs



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