Connecting to LinkedIn...

Vacancy Details

Science Pharmaceutical and Food

Regulatory Affairs Senior Specialist - Galway - 104250

Contract Type: Permanent
Location: Galway
Date: 17/05/2019
Job Reference: 104250
Contact Name: Bimi Felix
Contact Email:

Job Description

Regulatory Affairs Senior Specialist - Galway - 104250
Regulatory Affairs Senior Specialist

Our client, a pharmaceutical company in Galway & Dublin are currently looking to recruit a Regulatory Affairs Senior Specialist for their site.

About the role:
  • Life cycle management and regulatory filing maintenance activities (Preparation, review and submission of FDA required Annual Reports for Abbreviated New Drug Applications for  Institutional, Preparation, review and submission of amendments and supplements/variations to product marketing applications etc.)
  • New Product Submission Activities (Preparation of registration submissions, in eCTD format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required, monitoring the progress of registration submissions, responding to queries etc.)
  • Assessment of change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies and submit associated amendments / variations / supplements as required.
  • Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.
  • Actively participate in project teams, as required
  • Research information pertaining to marketing applications for other departments through the navigation of existing submissions and associated comments and regulatory documentation system
  • Maintain current knowledge of regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the Health Authority websites and attendance at conferences
Qualifications and essential functions for this position:
  • Minimum of a Bachelor's degree (or equivalent) in a science related discipline and 3-5 years’ regulatory experience in the pharmaceutical industry
  • A strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidance’s for Industry (particularly those dealing with sterile products)
  • Knowledge of the regulatory process pertaining to drug development, registration, review and approval
  • Knowledge of parenteral product submissions
  • Knowledge of cGMP awareness and compliance

For further information on this Regulatory Affairs Senior Specialist in Galway & Dublin please contact Bimi Felix on 086 8395533 /

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

Share this Job

“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“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

“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

Clients we are proud to work with