Regulatory Affairs Specialist
Our client, a pharmaceutical company based in Dublin, now seeks a Regulatory Affairs Specialist to ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures.
The successful candidate will be responsible for the preparation and submission of licence and variations to the HPRA, MHRA and other Regulatory Authorities as required.
Responsibilities of Regulatory Affairs Specialist:
Ensure all operations are fully compliant with licence details and updated in accordance with relevant guidelines and directives.
Ensure up to date files are maintained for all licensed products manufactured and/or released in manufacturing.
Review of relevant reports to ensure compliance with licence details and relevant guidelines and directives.
Review and approval of all new and revised master batch documentation, QC specifications and packaging work orders in line with licence details and relevant SOPs.
Identification, compilation and approval of Regulatory SOP’s.
Assist in the training of new artwork and regulatory personnel.
Set timelines for all licence and variation approvals.
Work to department KPIs.
Requirements for Regulatory Affairs Specialist:
Bachelor of Science Degree qualification a scientific discipline.
3+ years’ experience in a pharmaceutical industry.
Ideal candidate will have experience in submissions to notified body / regulators (HPRA, MHRA, and EU Bodies) for product approval.
EU submission experience will be an advantage, but not essential.
Ability to work well both on own initiative and across all levels, both internally and externally.
Ideally candidates with have strong organization and communication skills, both verbally and in writing.
Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.
Please phone Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Key words; FDA, GMP, R&D, NPI, HPRA, MHRA, Regulatory Affairs, Regulatory Compliance, Reg Affairs, Dublin, Kildare, Wicklow, Leinster, Pharmaceutical.