Senior 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
My client, a global pharmaceutical company with offices in Dublin City now have a new vacancy for a Senior Regulatory Affairs Officer.
Your role is to provide regulatory affairs support and manage International MAAs and Lifecycle activities for their current and actively growing range of pharmaceutical products, CAMs, R&D pipeline products’ therapeutic indications and international markets. Promote and facilitate team and corporate growth and success.
Key Responsibilities:
- Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, and ad hoc R&D pipeline)
- Preparation and filing of submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.
- Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
- Support the strategic and operational planning and registration of CAMs in global markets.
- Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).
Qualifications/Experience:
- >3 years 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)
- 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
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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