Job expirat
My client, one of Europe's leading specialty pharma companies, has an excellent opportunity for a Regulatory Affairs Specialist. This will give the ideal candidate the opportunity to work for a reputable and growing organisation while specialising in marketing and market-adapted product development.
Responsibilities will include :
Preparing renewal submissions and transfers for existing MA's
Preparing variation applications
Reviewing Validation protocols
Maintenance of licenses
Ensure that all new and revised prescribing information is progressed in the required format
Ensure IPHA SPC/ PIL compendiums and MIMS are updated accurately and within agreed timelines
To provide sound regulatory advice, and plan registration strategy to achieve the best possible approvals within agreed time frames
Candidates for this role will need:
To be a graduate in life sciences, of which pharmacy/pharmacology would be an advantage
A proven track record in a similar role, including dealing directly with the IMB
Have an in-depth knowledge of Regulatory Affairs and be familiar with Irish/EU legislation procedures and guidelines governing pharmaceutical products
Attractive compensation package with benefits
A new challenge and prospects of career progression within a growing company
A high level of responsability and independence
A supportive, friendly working environment
For further information or applications please contact alina.lapadatu@hayspharma.com
For further information or applications please email alina.lapadatu@hayspharma.com
Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.
Our client portfolio spans the world\'s leading life sciences companies in the pharmaceutical, biotechnology, generics, CRO and medical device industries. These organisations have come to depend on our professional service, innovative solutions and global reach.
With 21 offices around the world and over 350 people working through Hays Pharma and a global database of pharmaceutical professionals, we will successfully search and place over 1,000 pharmaceutical & biotech professionals this year. Hays Pharma provide the staff that help maximize returns on R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
