Regulatory Submissions Specialist

RHL

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Job ID :

7929


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Surrey,Surrey,


Key Skills :

regulatory affairs, regulatory submissions, cmc, regulatory, approvals, pharmaceutical, surrey, gmp


Salary :

Negotiable


Date Posted :

20 Jul, 2017



Company Name :

RHL


Location1 :

Surrey




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

upto 15%





Description

Regulatory Affairs 6 month contract (extension potential)with a global leading pharma client. Experience of European Submission Required

Job Description: Position Purpose
Supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets.
Ensure dossiers are produced, dispatched to assigned markets and are submission ready.
Work in collaboration across the regulatory organization with stakeholders to deliver efficiencies in Regulatory submissions and processes.

Primary Responsibilities
* Manage initial and post approval submissions for assigned markets
* Manage initial and post approval strategy and execution to ensure a submission ready dossier.
* Communicate changes to regulatory requirements
* Ensure submission packages are reviewed against local CMC requirements
* Contribute to local and regional regulatory initiatives
* Assist in ensuring internal regulatory processes and procedures are well documented

Technical Skill Requirements
Knowledge of the European regulatory environment and how this impacts regulatory strategy and implementation.

Qualifications
* Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
* Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
* Strong knowledge / background of EU regulatory procedures and requirements

Experience
* Experience in regulatory affairs or compliance preferably in human medicines - 5 years of experience as a minimum.
* Demonstrated regulatory experience with a pharmaceutical company
* Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
* Regulatory experience including knowledge of Europe submission product lifecycle management processes.

Job Title: Regulatory Affairs - Regulatory Submissions
Reference No: 234922
Location: Surrey
Job Type: 6 months contract


Company Name:

RHL


Headquarters:

The Cedars,Church Road


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

TN231RQ


Website:

www.rhl.co.uk


Employees:

less than 100


Industry:

Pharmaceutical Recruitment


City:

Ashford


Phone No. :

01233 658018


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

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