Company: Regulatory Professionals
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): Negotiable
Senior Regulatory Affairs Officer - Submissions Location: Dublin Salary: Up to €55,000 + Great Benefits Employment type: Permanent Do you want to work for a Top Generics company?
Senior Regulatory Affairs Officer - Submissions
Salary: Up to €55,000 + Great Benefits
Employment type: Permanent
Do you want to work for a Top Generics company?
Do you want to work for a reputable company offering a great benefits package?
Do you want to broaden your experience in a varied role?
Please note :- for the correct candidate this reputable organisation may offer a relocation package
An amazing opportunity has arisen to become part of one of the largest generics company in the world. The position will benefit anyone who is looking to broaden their experience within Regulatory Affairs as well as offer successful candidates the opportunity to work across a wide range of therapy areas in a fast paced, structured environment.
Main Job Responsibilities:
*Preparing and submitting Market Authorisation Applications (MAAs)
*Compiling the eCTD to specific country requirements
*Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU standards and corporate requirements
*Manage international regulatory submissions according to company strategy and ensure meeting registration deadlines
*Work as part of a team dealing with global registrations and providing regulatory support to all operational departments within the company, in particular Global IP and other hubs responsible for Global dossiers and related projects
*Maintain assigned products"e; Marketing Authorisations via timely variations and renewals submissions and their approvals
*3 - 6 years experience in Regulatory Affairs is desirable
*Detailed knowledge of EU current registration requirements
*Knowledge of specific national requirements
*BSc life science degree is essential
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
3rd floor 33 Blagrave Street Reading
|Tel:||+44 (0)118 9522 797|
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