Regulatory Affairs Manager
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Regulatory |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2832 |
| Job Views | 29 |
- Description
- TTeam Horizon is seeking a Regulatory Affairs Manager Team Horizon for a 12-month contract for our Dublin based client, who are a global biopharmaceutical manufacturer. In this role you will work under the responsibility of the Regulatory Affairs and Quality (RQA) department to ensure regulatory compliance of the company’s product portfolio and support the RQA Team in interactions with the MHRA, HPRA &MMA
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
Ensure timely submission and approvals of all registration relevant activities for
assigned products compliance with UK/IE/MT regulatory requirements where
applicable, including maintenance of such registrations in ARISE
Ensure timely submission of pre-registration applications in compliance with
UK/IE/MT regulatory requirements where applicable
Collaborate with Global Regulatory Affairs Leads (GRL’s) for assigned products,
including paediatric submissions to the MHRA,
Manage update of pack changes and ensure labelling compliance,
Provide regulatory input to stock and supply issues
Develop and maintain an effective professional working relationship with
assessors and administrative staff within the regulatory agencies
Coordinate the revision and distribution of additional Risk Minimization
Measures (aRMMs), such as educational materials to the HPRA & MHRA and
obtain timely HA approval
Collaborate with the Local Safety Officer (LSO) or the delegate regarding
tracking and implementation of local additional Risk Minimization Measures
(aRMMs),
Support the New Product Team (NPPT) for assigned pipeline projects where
and if required
Any other duties as assigned
What you need to apply:
Minimum of 5 years of experience in Regulatory Affairs within the
pharmaceutical industry
Hands-on operational working experience with all types of regulatory
submissions to Competent Authorities including general life product cycle
maintenance
Desirable for this role
Strong knowledge of all aspects of regulatory submission requirements, gained
in an affiliate role
Knowledge of updating, implementing, and distributing of educational
materials
Ability to pro-actively build team relationship and collaborate in a matrix
environment
Ability to support ad hoc projects including working in small to medium sized
project teams and work in a highly agile and flexible environment
