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Regulatory Submissions Coordinator DACH

Job Title: Regulatory Submissions Coordinator DACH
Contract Type: Permanent
Location: München (81249), Bayern
Industry:
Salary: €50000 - €60000 per annum + annual bonus, health inusurance
Start Date: Jan 2017
Reference: 67915-PHARM-JHY
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: November 08, 2016 10:40

Job Description

Regulatory Submissions Coordinator / Senior Regulatory Submissions Coordinator

Location: Munich, Germany
Full time

Description:

My client is a global, full-service Clinical Research Organisation (CRO) specialising in a multitude of therapeutic areas
Headquartered in the USA and active in over 45 countries across the globe
They are growing steadily and looking to add further talent to their team

Role summary:

I am currently seeking a full-time, office-based Regulatory Submissions Coordinator to join my client's Clinical Operations team
This position will work in a team to accomplish tasks and projects that are instrumental to the company's success
If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you

My client's philosophy is to empower their teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our partners
Their employees embody their values and their approach to serving clients
They work hard, understand their high expectations, and rise to the challenge
In return they are rewarded with interesting projects, career advancement, and recognition and exposure to their international footprint

Duties & main responsibilities:

* Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland
* Prepare and submit responses to queries and amendments to clinical trial applications
* Ensure submissions comply with applicable regulations and guidance documents
* Advise sponsors on changing regulations and compliance requirements
* Track submissions and ensure timely filing of documents
* Collection of essential documents and preparation essential documents packages for drug release

Qualifications / Experience required:

* Bachelor's degree in life sciences
* Excellent organisation and communication skills
* Knowledge of Microsoft® Office
* Hands-on experience preparing, reviewing, and submitting regulatory documentation
* At least two years of work experience as a Regulatory Submissions Coordinator
* Minimum 4 years' experience for the Senior Regulatory Submissions Coordinator position