Description
It is an exciting growth phase for this organisation and there is significant expansion plans. The scale of expansion and investment is extremely significant. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact. You will get great exposure to cutting edge systems and will get to see the product right through to market.Role:
- Work as a member of R&D with colleagues in Dublin and the UK and with commercial manufacturing, to ensure the successful technology transfer and on time file submission of an inhalation product to the US and EU.
- Compile, review, execute and report process development and clinical protocols to assure appropriate data for regulatory submissions and compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale.
- Co-ordinate the compilation of technical components of the regulatory submissions.
- Prepare technical aspects of the regulatory submission for initial filing and for post approval changes and variations in the US and Europe.
- Author, and coordinate the completion of technical reports to support product submission filings.
- Document and coordinate the investigation of product performance issues.
- Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results.
- Liaise with site functions - logistics, planning, QA, QC, Operations, Regulatory Affairs to support process transfers and regulatory filing
- Execution of process development/demonstration or validation studies and write-ups.
Qualifications and essential functions for this position:
- The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast paced environment.
- Science / Engineering qualification (minimum of degree), with 3 years relevant experience in Technology Transfer, Tech Services or Process Development.
- High proficiency in Microsoft Excel/Powerpoint/MS Project etc.
- Previous experience with new product introduction and technology transfer required.
- An ability to work flexibly in a changing environment. An ability to multi-task, good attention to detail and priority management essential. Ability to work well under deadlines and pressure
- Strong technical ability including methodical approach to problem solving and strong technical writing skills.
- A strong understanding of regulatory guidance and previous experience in regulatory submissions is required.
An excellent salary is on offer alongside benefit package including pension, healthcare and bonus.
Apply now for immediate consideration.