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Vacancy Details

Secreterial & Administration

Regulatory Affairs Support Co-ordinator - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 10/12/2018
Job Reference: 100278
Contact Name: Vanessa Lynch
Contact Email: team@hero.ie

Job Description

Contact: Vanessa
Email: recruit@hero.ie
Telephone: 086 0462367

Regulatory Affairs Support Co-ordinator

Our client, a pharmaceutical company in Co Galway is currently looking to recruit a Regulatory Affairs Support Co-ordinator for their site.

Essential Duties And Responsibilities:
? Timely compilation and submission of regulatory documents:
Export applications (medical and veterinary):
Dossier submissions, responses (including scientific arguments), fees, samples, artwork, renewals, variations, notarized/legalized documents, pharmacovigilance
EU Applications (medical and veterinary):
preparation of administrative section, formatting into eCTD/NeeS/vNeeS, submissions through CESP/via CD, organising notarized/apostilled documents, translations.
? Communicating on a regular basis with the Supervisor / relevant Managers to give regular feedback on regulatory status of export applications.
? Transfer of data from Regulatory Department to relevant internal and external parties following registration grant of export applications.
? Maintenance of Regulatory filing systems, indexes and database.
? Assist supervisors / managers in preparing and maintaining the department budgets.
? Preparation and maintenance of SPC and Labelling system for regulatory applications (EU and Export).
? Ordering literature references and maintaining the reference files and index.
? Pharmacovigilance: Forward any incoming reports (post, e-mail, fax or in Person) regarding Pharmacovigilance / Adverse Action Report to the relevant QPPV in a timely manner.
? General Office Duties including: Typing (letters/e-mail), maintaining office stationary, sorting post, organising translations, organising couriers on behalf of Regulatory department.

Person Specification:
? Attention to detail in generation of export dossiers, reports etc.
? Ability to work on multiple projects simultaneously.
? Communication skills with external and internal customers.
? Minimum 1-3 years in a Regulatory or Scientific environment would be an advantage
? Experience in busy problem solving environment with the ability to work to tight deadlines and on own initiative.
? Good communication skills both written and orally.
? Good knowledge of guidelines and requirements for export applications.
? Good IT skills and computer literate preferably to ECDL level.
? Strong Customer Service focus both internally and externally
? Good project management

For further information on this Regulatory Affairs Support Co-ordinator role in Galway please contact Vanessa on 086 0462367 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
More

Clients we are proud to work with

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