Company: Regulatory Professionals
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Officer - Submissions Reference: J26120 Location: Dublin Salary: Up to €35,000 - €55,000 + Healthcare Allowance, Pension Scheme, Bonus Scheme, 23 Days holiday
Regulatory Affairs Officer - Submissions
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?
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
*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
3rd floor 33 Blagrave Street Reading
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