Regulatory Executive – EU & USA
Job ID: JOB-11780
Regulatory Executive – EU & USA
A leading pharmaceutical manufacturer is recruiting for a Regulatory Executive specialising in EU & USA registration to join their team in Galway on a permanent basis.
This is an opportunity to be part of a dynamic team within the Vet Regulatory Affairs function. We are looking for individuals who will support and drive the vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role you will report into the EU/US Registration Manager.
Basic Summary: To support the US/EU Registration Manager in the process of development of new products, attaining and maintaining Product Licenses / Marketing Authorizations for the US markets for the business and customers.
Essential Duties and Responsibilities:
- The functions of the Registration Executive include but are not limited to the following tasks:-
- Compilation and submission of EU/ ANADA regulatory dossiers in relation to FDA applications
- Review and submit documents associated with EU / ANADA applications.
- Ensure QbD approach in Module 3 / CMC submissions in accordance with relevant requirements.
- Ensure compliance with all relevant guidelines.
- Perform technical validation of all documentation prior to submission ensuring data are in full compliance with relevant requirements.
- Prepare and manage all appropriate bioequivalence or biowaiver applications for medical applications.
- Preparation and management of response to questions from authorities or customers during procedures (new dossier, change notices, etc.) within assigned timelines.
- Provide guidance and training where necessary to other members of regulatory teams or supporting areas to achieve right first-time targets for application approval and reduce post submission queries.
- Review of potential dossier changes and submission of any required changes to submissions
- Ensure post approval updates submitted within required timeframes.
- Ensure regulatory affairs files are maintained to support compliance with regulatory requirements.
- Provide support to R&D team for regulatory issues/questions.
- Provide support to new and currently marketed products as necessary. This includes reviewing labelling and other post-market activities.
- Support internal and external audits by regulatory agencies as required.
- Support pharmacovigilance responsibilities for EU and US market as required.
- Transfer of data from Regulatory Dept. to Customers, Product Launch, QA, QC and Production
- Participate in cross functional activities as required.
- Other responsibilities as required or assigned by manager.
- Ability to work to tight deadlines while taking a right first-time approach.
- Ability to organise tasks in order deliver a project on time as set out on project plans.
- Ability to learn new skills as appropriate to the task and apply going forward.
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands.
- Ability to build strong collaborative relationships with others.
- Excellent communication skills, both verbal & written.
- Ability to prioritise decision making differentiating between urgent and non-urgent.
- Maintain the highest standards of behaviour.
- Strong analytical ability and associated problem solving.
- Flexible and willingness to learn to develop technical skills.
- Ability to take a methodical, systematic and structured approach to organising work.
- Positive and proactive person who is energised by having responsibility.
- Practical, action-orientated approach to managing priorities.
- Scientific qualification and background preferably B.Sc. or equivalent.
- Minimum 5 years’ experience in Regulatory Affairs.
- Minimum 2 years in a US and EU regulatory/R&D environment preferably with experience of generic applications. In-depth knowledge of EU and US regulatory submissions would be an advantage.
- Experience in busy problem-solving environment with the ability to work to tight deadlines and on one’s own initiative.
- Detailed technical knowledge of products and processes.
- Strong Customer Service focus both internally and externally.
- Excellent command of technical English (both written and spoken)
- Ability to work on multiple projects simultaneously.
- Communication skills with external and internal customers.
For further information on this RA Executive role in Galway please contact Clara Burke on 086 8168273 or firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website – https://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
Job ID: JOB-11850 Supplier Engineer Our client, a leading medical device company in Galway is seeking to recruit a Supplier…
Job ID: JOB-11849 R&D Biomaterials Senior Engineer Our client a leading medical device company in Galway are seeking applicants for…
Job ID: JOB-11845 Control Systems Engineer Position Summary: Our client, based in Galway are recruiting for an experienced Control Systems…