Regulatory Affairs Officer
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Negotiable Depending On Experience
- Start date
- 25 Mar 2021
- Closing date
- 24 Apr 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
On behalf of my client, a global pharmaceutical company based in Dublin City. I am currently recruiting for a Regulatory Affairs Officer.
RESPONSIBILITIES
- Preparation and submittal of Life-Cycle Maintenance regulatory submissions for EU and global markets
- Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
- May support on some R&D regulatory projects
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, Globally based Regulatory Managers).
- Prepare status reports and metrics for assigned projects
- Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
REQUIREMENTS
- Degree in Pharmacy or life science-related degree
- Minimum 2 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets.
- Preparation of relevant CTD documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations
- Experience of EU DCP and MRP MAAs
- Experience of emerging markets / international RoW markets and regulatory filings
- Quality control review of technical/ regulatory documents
Full Job spec available on request.
For full details contact Ciara at cnugent@thornshaw.com or call +353 1 2784671
Thornshaw Scientific Recruitment is a leading Irish Provider of Specialist Scientific Recruitment. Part of the CPL group. www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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