Regulatory Affairs Officer - Pharma - NEW**
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Unavailable
- Start date
- 18 Jul 2019
- Closing date
- 2 Aug 2019
View more
- Discipline
- Regulatory Affairs, CMC, Compliance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Regulatory Affairs Officer: Dublin City Centre Based
PURPOSE
We are currently recruiting for a Regulatory Affairs Officer to join a rapidly growing Global Regulatory Affairs team located in Dublin. Your role will be to prepare, contribute to and manage MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, therapeutic indications and international markets.
RESPONSIBILITIES
Acts as responsible Regulatory Team member for assigned regulatory projects
- Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, CMC authoring and \ or updates as required.
- Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional Heads).
- Understands the Scope of Work, timelines and deliverables for a given project.
- Prepare status reports and metrics for assigned projects
- Perform assigned work according to current best regulatory practice and in compliance with current legislation and regulatory guidelines.
- Any other duties as assigned by your Manager
- MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in Pharmacy or life science-related degree plus at least 2 year’s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets
- 2-4 years 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)
- Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling experts
- Experience of EU DCP and MRP MAAs
- 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, timelines, budgets and filing options
- Compliance with SOPs Change controls and regulatory best practices
- Pharmaceutical artwork review and sign-off
- Project management experience - an advantage
- Experience of Women’s and/or Men’s healthcare – an advantage
For full details and confidential discussion please contact Tina at +353 1 2784671 or email your cv to tdunne@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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