Jobs
Paraxel are currently recruiting for Consultants in their Kilmainham Dublin office. The website link is https://jobs.parexel.com/job/dublin/regulatory-affairs-consultant/877/9246740.
CMC Consultant Overview:
A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides.
A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
Qualifications:
-Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
-Several years of experience in an industry-related environment
Skills required:
-Variation/Lifecycle Maintenance experience EU/RoW: Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.
-Change Control assessment experience
-Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
-Proactive’ and ‘efficient working method
-Strict adherence to timelines (both internal and HA deadlines)
-Excellent interpersonal and intercultural communication skills, both written and verbal
-Client-focused approach to work (Quality)
-Results orientation
-Teamwork and collaboration skills
-Critical thinking and problem-solving skills
-Proficiency in local language and extensive working knowledge of the English language
Posted 25th Oct 2018
EirGen Pharma in Waterford (part of OPKO, Miami, US) are recruiting a number of Science graduates to join their Regulatory/Clinical Affairs team with immediate start. The Regulatory department has a structured training program for graduates delivered by both internal and external trainers with extensive experience of Global Regulatory Affairs. This is an exciting opportunity to join an expanding Regulatory Affairs department supporting EirGen's newly built R&D facility in the space of New Drug Development and niche Generic drug development in a variety of dosage forms, including Oral Solid Dose – immediate and modified release, soft capsules and liquid fill hard capsules and Fill/Finish for both small molecules and biologics. See job description for further information EirGen Reg Affairs Office positions_Aug 2018.
For anyone who wishes to apply they can send a copy of their CV to HR@Eirgen.com.
Posted 19th Oct 2018
The HPRA are currently recruiting for a Pharmaceutical Assessor, in the Pharmaceutical Assessment – Human Products Authorisation and Registration Unit. Would be an ideal position for a pharmacist with some industry experience.
Irish Medicines Verification Organisation (IMVO) are looking for an experienced quality professional for the role of Quality Manager. This will be a part-time (0.5 FTE) position, based in Dublin. For further information, please see the role profile IMVO Quality Manager (part-time).
To apply or to make an informal enquiry, please contact Leonie Clarke, IMVO Project Manager (email leonie.clarke@imvo.ie).
IQVIA Europe (formerly Quintiles) are recruiting for their growing Global Regulatory Affairs Department. The new positions would be suitable for pharmacists with at least five years of experience in Regulatory Affairs or a similar area of the pharmaceutical industry.
For further details, see the regularly updated IQVIA jobs portal link: https://jobs.iqvia.com/en-US/search?keywords=regulatory%20affairs&location=&facetcountry=gb
Unless expressly stated "Office Based - Reading UK", the positions can be remotely based in any EU/UK country subject to agreement of the UK-based managers. Successful applicants who reside in Dublin are encouraged to utilise the IQVIA Ireland Office in Eastpoint Business Park, Fairview as their remote working base.
For informal enquiries, please contact brian.lalor@iqvia.com.
The HPRA are currently recruiting for a Pharmaceutical Assessor, in the Pharmaceutical Assessment – Human Products Authorisation and Registration Unit. Would be an ideal position for a pharmacist with some industry experience.
Sanofi Waterford is currently recruiting for an Regulatory Site Officer for their Regulatory Affairs Department. Position may be suitable for Pharmacists making transition across to industry.
For further details, see the job description Sanofi Regulatory Site Officer.
For enquries/applications, contact Jadwiga.Zmuda-ext@sanofi.com
Astellas is currently recruiting for an Affiliate Lead for their Regulatory Affairs Department.
For further details, see the job description Astellas RA Affiliate Lead position.
Eirgen in Waterford are recruiting for a Regulatory Affairs Officer based at the R&D Centre in Waterford City. This is an entry level position which would be suitable for a pharmacist with some industry experience.
For further information, see Eirgen Regulatory Affairs Officer position Jan 2018.
LEO Pharma are recruiting for a permanent senior position in the Manufacturing, Science and Technology Finished Goods department (MSAT FG). This involves the management of process development and technology transfer projects and the provision of technical support.
The successful candidate will have:
- an honours degree in pharmacy
- 3 years’ experience in product/process development or related post-graduate research
- excellent teamwork skills as well as being capable of working on his/her own initiative
- strong capabilities with respect to dealing with ambiguity
- excellent collaboration and communication skills.
Please apply with a recent CV via the following link https://my.hirehive.io/leopharma/jobs/32741/manufacturing-science-and-technology-finished-goods-msat-fg-senior-professional-p5-dublin
Useful Links
- Academy of Pharmaceutical Sciences (APS)
- European Industrial Pharmacist Group (EIPG)
- European Industrial Pharmacists Group Newsletter
- European Medicines Agency (EMA)
- Health Products Regulatory Authority (HPRA)
- Irish Institute of Pharmacy (IIOP)
- Irish Medical Device Association (IMDA)
- Irish Pharmaceutical Healthcare Assocation (IPHA)
- Pharmaceutical Managers Institute (PMI)
- Pharmachemical Ireland
- The Pharmaceutical Society of Ireland (PSI)
- UK & Ireland Controlled Release Society (UKICRS)
- The Organisation for Professionals in Regulatory Affairs (TOPRA)
Find out more about the PBF and the work they do 