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Job Details

Regulatory Affairs Assistant - Essex/Kent - £22k + package (pension, life assurance, free lunch)

Company: JCW Life Sciences
Location:
Reference: WBRAA
Closing Date: 10 Feb 17
Type: Permanent
Salary (£): 20,000 - 30,000
Benefits: Pension + Life Assurance + Free Lunches

Job Summary:

A UK-based Speciality Pharmaceutical company is looking for a Regulatory Affairs Assistant to support the Regulatory Activity across a multitude of European projects. A great opportunity career-oriented and motivated junior candidates in the pharmaceutical Regulatory Affairs, this company also pays for staff lunch, snacks and drinks (so you can save money)!

Requirements:

DETAILS

Role: Regulatory Affairs Assistant

Company: Speciality Pharmaceutical Company

Location: Essex / Kent

RESPONSIBILITIES

This role is aimed at supporting the Senior Regulatory Office with Regulatory activity and Compliance in European markets and alongside the Commercial Team. Regulatory work is aimed at the appropriation and maintenance of licenses in key markets: applications, variations, renewals and MAAs (market authorisation).

Details:

  • New filings, variations, and renewals of marketing authorisations for, including fee requests,
  • artwork, filing, versioning and data management.
  • Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with the current
  • legislation and registered particulars 
  • Carry out administrative activities where necessary to ensure the effective operation of the department.
  • Assist and provide support in the preparation, distribution and follow up of registration documentation to affiliate
  • organisations/agents in other European countries as required.
  • Assistance with EU pharmacovigilance and any quality issues arising from products or its associated
  • marketing authorisations. 

REQUIREMENTS

This company is looking for a motivated Regulatory Affairs applicant with 0-1 years' experience within the industry and a good understanding of regulatory processes

or:

  • BSc. or MSc. in Pharmacy, Chemistry or related Science (preferred)
  • Experience in local Regulatory Affairs/Registration, preferably in generics
  • Good knowledge in post-marketing authorisation including variations (Type IA/Type IB/Type II and PIQ notification/full applications) and renewals.
  • Working knowledge of electronic documentation management System (eDMS).
  • Experience of RMP, PSMF, GVP modules I-IVI requirements. EVMPD/XEVMPD/PTs

 

NOT THE RIGHT POSITION FOR YOU?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to william.bellynck@jcwresourcing.com or call 0203 589 9286 for a confidential discussion about potential opportunities.

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

JCW offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

JCW

JCW is a recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;

  • Pharmacovigilance/Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Medical information
  • Medical Writers
  • Compliance
  • Audit
  • Validation
  • Clinical trials
  • Clinical research
  • Project Management

If you are interested in opportunities, but feel this position is not suitable, please feel free to get in touch on william.bellynck@jcwresourcing.com or 0203 589 9286.

My LinkedIn Profile

https://uk.linkedin.com/pub/william-bellynck/a1/48/19a

A Recruitment Consultant specialising in the Life Sciences sector, placing Clinical Research professionals into interim and permanent positions across the United Kingdom.

If you are a professional looking for work or a hiring manager looking to employ in the Clinical Research space please feel free to reach me on 0203 589 9286 or via email: william.bellynck@jcwresourcing.com

KEYWORDS

Clinical, clinical research, clinical project manager, clinical study manager, clinical trial manager, clinical development, clinical research associate, cra, senior cra, medical, research, regulatory, manager, sales, data, affairs, regulatory affairs, chemist, Marketing, quality, associate, management, director, project, safety, pharmacovigilance, writer, graduate, information, validation, drug, development, pharmaceutical, statistician, representative, business, scientist, pharmacist, trainee, chemistry, sas, drug safety, assurance, clinical research, health, analyst, engineer, statistics, qa, medical, information, nurse, physician, London, , regulatory, variation, generic, pharmaceutical, submission

Apply for this job: Regulatory Affairs Assistant - Essex/Kent - £22k + package (pension, life assurance, free lunch)

Contact Information:

Address:  Head Office
27-32 Old Jewry
London
EC2R 8DQ
England
Tel:  +44 (0) 203 589 9300
Fax:  +44 (0) 203 006 8808
Website:  Visit Our Web Site

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