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Job Ref.: 1696

Job Title: Regulatory Affairs Executive (3 years experience) - Pharmaceuticals - Dublin - December 2018 - Immediate Vacancy

Posted Date: 13/12/2018

Sector: Regulatory Affairs

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Regulatory Affairs Executive (3 years experience) - Pharmaceuticals - Dublin - December 2018  - Immediate Vacancy

Our client, a major commercial pharmaceutical company based in Dublin, currently have a vacancy for a Regulatory Affairs Executive to join their Medical Affairs team. The position is a full time permanent role

Candidates should have the following skills:

- Degree in Pharmacy or life Science.

- Excellent verbal and written communication skills

-     Minimum of 3 years experience in Pharma Regulatory Affairs

- Computer literacy.

- Analytical and negotiation skills.

- Knowledge of regulatory requirements for medicines in EU/Ireland.

KEY TASKS

Regulatory

Ø To plan, prepare, submit and follow-up applications for marketing authorisations and clinical trial approvals in Ireland in accordance with commercial objectives. To maintain these by means of variation and renewals.

Ø To provide regulatory support for manufacturing sites and logistics management, including participation in regulatory compliance procedures.

Ø Ensure prompt resolution of regulatory issues affecting the Irish business. Communication of significant regulatory issues/developments to commercial colleagues.

Ø Responsibility for submission of PSURs to the IMB for product responsibilities in conjunction with the Affiliate Pharmacovigilance Head.

Ø To optimise regulatory approvals by appropriate negotiation with regulatory authority staff and/or corporate regulatory staff.

Ø To maintain regulatory based labelling (SmPC, PL, etc) as appropriate.

Ø Review product information and promotional material before release.

Ø Provision of monthly regulatory report to Regulatory Affairs Manager.

Ø To maintain awareness of changes in the Irish & EU regulatory environment.

Ø To work within applicable Corporate and local SOPs.

Ø To deputise for other members of the Regulatory Department as appropriate.

Ø Responsibility to report product quality and safety issues such as individual case safety reports (ICSRs), product technical complaints (PTCs) and reports of drug exposure via parent (DEVP) occurring in association with any product in an expeditious manner to the company in accordance with company SOP.

Ø Responsibility for risk assessment (irrespective of the origin of the risk) within your domain of responsibility

 

An excellent salary plus benefits package will be offered to the right individual.

For further information, please contact Paul Flanagan at Dublin (01) 805 5522 or e mail your c/v in the strictest confidence to paul@pharmasolutions.ie

 

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