Regulatory Affairs Manager

Galway  ‐ Onsite
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Keywords

Description

A leading generic manufacturing pharmaceutical company in Galway is looking to hire a Regulatory Affairs Manager. This is a great opportunity to join an expanding organisation that have grown year on year and have continuously been adding to their already vast range of products.

Brief summary:
Oversee and manage the process of dossier preparation, submission & maintenance of products and attaining and maintaining Product Licences/Marketing authorisation. As manager you will also oversee and manage the communication of regulatory information from the company to the responsible Pharmacovigilance group.

Required Skills:
- DCP/MRP and generic applications
- Preparation of Overhead and Annual Budgets
- CTD experience
- Strong IT skills

Desired Skill:
- Strong attention to detail
- Strong communication skills

Day to Day of the Role:
- Preparation and compilation of CTD regulatory dossiers Module 1 - 5 for EU National and MRP/DCP Marketing Authorisation (MA) applications for key projects.
- Review dossiers prepared by/or on behalf of the company prior to submission.
- Review of protocols for Bioequivalence studies and Biostudy reports.
- Set and manage timelines for timely response to queries raised by the regulatory authorities and Customers
- Manage & oversee Artwork review and approval in Regulatory
- Manage & oversee transfer of data from Regulatory Dept to NPI, QA, QC and Production.
- Maintain & update TMS for the Regulatory office. Update payroll with monthly payroll details.
- Manage & maintain department measurements in line with Dept. KPI's.
- Agree KPI's with RA Executives in the department (and carry out mid-year reviews with direct reports).
- Prepare, maintain and manage department SOP's.
- Preparation of overhead and annual budgets for areas of responsibility..
- Participate in conference calls with Customers (potential & current) as a regulatory to assist in regulatory advice.
- Liaise with Customers and hold conference calls or face to face meetings to discuss regulatory strategies, deficiencies and any other customer query that may arise.

Minimum Experience:
- 5 years in a regulatory environment in the pharmaceutical industry
- Degree in a Science related subjected

This is a permanant role woth an excellent salary of between €60,000 and €70,000 is on offer plus benefits. If you are interested in this role please contact me, Niamh Irwin, on for more information and for immediate consideration.
Start date
04/2014
From
Real Staffing
Published at
28.03.2014
Project ID:
686029
Contract type
Permanent
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