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Job Details

Regulatory Affairs Officer - Submissions

Company: Regulatory Professionals
Location: Dublin
Reference: J26120
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Regulatory Affairs Officer - Submissions Reference: J26120 Location: Dublin Salary: Up to €35,000 - €55,000 + Healthcare Allowance, Pension Scheme, Bonus Scheme, 23 Days holiday

Requirements:

Regulatory Affairs Officer - Submissions
Reference: J26120
Location: Dublin
Salary: Up to €35,000 - €55,000 + Healthcare Allowance, Pension Scheme, Bonus Scheme, 23 Days holiday
Employment type: Permanent

Do you want to work for a leading 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 with opportunities to progress?

Company/Role Overview:
An opportunity has arisen to become part of one of the largest generics companies 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)
*Liaising with Regulatory Authorities and the Ministry of Health
*Compiling the eCTD to specific country requirements
*Assist in managing International Regulatory Submissions
*Compile product reviews and PSURs
*Archive the registration documentation

Candidate Requirements:
*1 - 3 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
*Submissions experience is beneficial

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.

Keywords: Regulatory, Ireland, Compliance, Submission. MRP, DCP. National, CP, Officer, Associate, Administrator, Post, Approval, Maintenance, Variations, Licences, Renewals, EU, UK, Relocation

Apply for this job: Regulatory Affairs Officer - Submissions

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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