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June 20 2018

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Offer: Regulatory Affairs Manager:Life Science Recruitment

Job description:

Regulatory Affairs Manager

Life Science Recruitment


   » Dublin
   » Not disclosed
   » Permanent full-time
   » Updated 14/06/2018
   » Sinead Cullen this job is expired SaveSave Apply Now

Job detail


Our client is an international pharmaceutical discovery organisation and they are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis.
 

Regulatory Affairs Manager
Our client is an international pharmaceutical discovery organisation and they are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis. The ideal candidate will be a dynamic individual, who is self-driven, organized and capable of working on their own initiative in a start-up environment.

Responsibilities
• Coordinate, prepare and be accountable for all regulatory affairs related activities such as clinical trial applications, organization and preparation of regulatory advice meetings and compilation of IMPDs and comparable documents
• Provide the cross-functional team with regulatory input in order to obtain timely approvals and contribute to the product development strategy planning
• supervise internal activities and external vendors to ensure compliance with all regulatory requirements

Requirements
• Life Science degree and a minimum of 5 years EU/US Regulatory Affairs practice in a pharmaceutical company/ CRO
• Thorough knowledge of the clinical trial application process in the US and Europe
• Exposure to the NDA and MAA submission process
• practice dealing with regulatory authorities in relation to investigational medicinal products is a requirement
• Must have excellent oral and written communication and presentation expertise
• International and domestic travel may be required

If you would like more information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252

PLEASE APPLY DIRECTLY BY CLICKING HERE

Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.

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Ref: AQWO-662653
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Life Science Recruitment


   »  


   » 12 Fitzwilliam Square, Dublin 2
   » 01 685 45 45
   » applications@lifescience.ie
   » http://www.lifescience.ie



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Dublin
Company Type Employer
Post Date: 06/14/2018 / Viewed 10 times
Contact Information
Company: Life Science Recruitment
Contact Email: applications@lifescience.ie


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