Regulatory Affairs Coordinator

Job type:
permanent
Start:
n.a
Duration:
n.a
From:
Quanta Consultancy Services
Place:
Netherlands
Date:
04/29/2016
Country:
flag_no United Kingdom

Project description:
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Regulatory Affairs Coordinator



Your primary activities will be providing administrative regulatory support during filing and review of new submissions and variations, in order to safeguard submissions according to EU requirements. You will be responsible for the planning and co-ordinating of module 1 documents for new submissions, variations, CHMP referrals, FUM,to ensure timely submission.



You will be responsible for drafting of module 1 components and organising the gathering of the module 1 components. You will collaborate closely with Regulatory Operations to establish submission timelines and content of Module 1. You will also collaborate closely with subsidiary Registration Managers, in order to ensure timely submission.



You will be responsible for the preparation of the English Product Information (SmPC, label and leaflet) in collaboration with WPL and for the centralised procedure, supervising and co-ordinating the translation process to ensure timely submission to EMA. You will provide other administrative support related to Marketing Authorisation Applications to Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed. You will ensure updates to regulatory databases and keep up-to- date with EU procedural requirements and legislation. As Regulatory Coordinator you will participate as Subject Matter Expert in relevant workstreams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff.



 Required Experience Qualifications



- University or bachelor degree, preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.

- Good organisational skills, proven ability to multi-task, excellent written and verbal communication skills in English.

- Can work across bounderies: demonstrates the ability to act as intermediary across bounderies

- Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation

- Demonstrates ability to co-ordinate tasks with others for timely completion and to avoid setbacks

- Demonstrates the ability to check regulatory documents to determine accuracy and find potential errors

- Understands the end-to-end pharmaceutical lifecycle

- Considers the recent innovations when formulating recommendations

- Evaluates activities and business processes across functions, identifies aereas in need for improvement and leads efforts for solution design and implementation

- Applies and advises policies and procedures and applicable regulations and standards