Senior Regulatory Affairs Manager - Clinical Trials

Lawrence Harvey

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Job ID :

8763


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Frankfurt,Frankfurt am Main,


Key Skills :

Regulatory Affairs,ISO 13485, Pharmaceuticals, Medical Devices, CMC, Pharma, Senior Regulatory Affa


Salary :

Negotiable


Date Posted :

19 Sep, 2017



Company Name :

Lawrence Harvey


Location1 :

Frankfurt am Main




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Are you the next Senior Regulatory Affairs Manager with a focus on Clinical Trials?



Senior Regulatory Affairs Manager - Clinical Trials (m/f)



I am currently looking for a Regulatory Affairs professional with significant experience within the area of Clinical Trials to take on an absolutely fantastic opportunity for a leading pharmaceutical company based in the Hessen region.



The position:



* Coordinating and overseeing approvals for CT's with pharmaceutical products and medical devices globally
* Creation of dossiers and all neccessary documents for the submission of approval applications for CT's, with significant levels of guidance to team members
* Overseeing the processes involved in the submissions to the appropriate Regulatory bodies and following through with them in association with team reps
* Development of Regulatory Strategies for assigned projects
* Creation and maintenance of CCDS
* Regulatory advice, and consultations with authorities
* Liasion point for all relevent authorities



Your experience:



* Completed studies in pharmacy, biology or similar
* Over 4 years experience in RA
* Practical knowledge of how to manage approvals for clinical trials (CTA)
* Solid knowledge of all stages of Drug Development
* Thorough knowledge of up to date regulatory requirements
* IMPD Knowledge
* Very good knowledge of both German and English, written and spoken



If you are, or know a suitable candidate that is determined to take the next step in their career and really challenge themselves with a position of high repsonsibility, then please either respond to this advert, or alternatively send your application to d.perkins@sciproglobal.de directly.



Good luck!!


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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