Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Regulatory Affairs Administrator

Company: Thornshaw Recruitment
Location:
Reference: TD9547
Closing Date: 21 Oct 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

My client a leading Healthcare business now have a vacancy for a Regulatory Affairs Administrator for their offices in South Dublin. This role is a full-time permanent position.

Requirements:

My client a leading Healthcare business now have a vacancy for a Regulatory Affairs Administrator for their offices in South Dublin.   This role is a full-time permanent position.

Key responsibilities for the role:
The successful candidate will be involved in assisting with the preparation, creation and submission of new Marketing Authorisation Applications, variations and RFIs (response for further information) for submission to regulatory authorities, in compliance with regulations & guidelines.


The key responsibilities will also include, but are not limited to the following;
• Assist with the preparation, creation and submission of new Marketing Authorisation Applications in compliance with regulations and guidelines.
• Compile appropriate documents/files etc. for submission to regulatory authorities/external companies.
• Assist with the drafting of departmental procedures and associated documentation.
• Maintain and administer the change control log and associated documentation
• Participation and compliance with the quality management system.
• Maintain databases of key regulatory activities, documentation and confidential company files.
• Develops and maintain familiarity with submission of applications to regulatory authorisations in line with applicable legislation, guidelines and current industry practices.
• Prepare and compile reports, presentations and meeting information.
• Arrange travel flights/hotel accommodation/visas and meetings.
• Provide administrative support to all functions of the Regulatory Department  and to other departments regarding the provision of regulatory and technical information.
• Project work as and when required.
Qualifications and Education:


• Business Degree or equivalent
• 2 to 3 relevant experience in the healthcare industry.
• Strong proficiency of Microsoft office.
Personal Characteristics and Experience Profile Required:
The principal skills, experience and personal characteristics, which the successful candidate will be able to demonstrate, are:
• Excellent personal organisation and planning skills demonstrated through prioritisation of workload and appropriate allocation of time in line with agreed project plans with a view to achieving business targets.
• Good attention to detail and precision in all aspects of work.
• Ability to work independently or as part of a team as required.
• Demonstrates effective communication style appropriate to audience and situation
• Establish and maintain good working and interpersonal relationships
• Good understanding of commercial implications of role


For further information contact Tina at+353 1 2784671 or email your CV in confidence to tdunne@thornshaw.com.   For a list of all current vacancies log on to www.thornshaw.com
 

Apply for this job: Regulatory Affairs Administrator

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.