Regulatory Affairs Officer
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Negotiable
- Start date
- 14 Sep 2021
- Closing date
- 21 Sep 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
My client, a global pharmaceutical company now have a new vacancy for a Regulatory Affairs Officer to join the growing Global Regulatory Affairs team located in Dublin.
Your role will be to prepare, contribute to and support their international registrations and Lifecycle activities for their current and actively growing range of pharmaceutical products.
RESPONSIBILITIES
- Acts as responsible Regulatory Team member for assigned regulatory projects
- Active member in a busy high quality globally focused regulatory team
- Preparation and submit Life-Cycle Maintenance regulatory submissions for EU and global markets
- Prepares and/or reviews regulatory documentation for submission to regulatory authorities.
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Clinical, Medical, Pharmacovigilance and exglobal market Regulatory Managers).
- Maintain status reports for assigned projects
- Always perform assigned work according to current best good regulatory practice, SOPs and in compliance with current legislation and regulatory guidelines.
- Learn, develop and train
Qualifications & Experience required:
Degree in Pharmacy or life science-related degree plus at least 18 months relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets
- >18 months’ pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g., Variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)
- Familiarity of the CTD structure and content
- Experience of emerging markets / international RoW markets and regulatory filings
- Quality control review of technical/ regulatory documents
- Understanding of Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices
- Publishing: eCTD and or NEES
- Pharmaceutical artwork review experience
- Project management experience - an advantage
- Experience of Women’s and/or Men’s healthcare – an advantage
For further detail email Tina at tdunne@thornshaw.com or call +353 1 2784701 or 087 6811990 Thornshaw Scientific is a division 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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