Regulatory Affairs Specialist ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees.
We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets.
We are now seeking an experienced Regulatory Affairs Specialistas weexpand.
OVERALL ROLE OBJECTIVE The Regulatory Affairs Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development.
SPECIFIC RESPONSIBILITIES Reporting To: Manager Regulatory Affairs REQUIREMENTS: Preparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions).
Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA Review of data intended for submission and advise regarding any deficiencies or issues.
Ensure on-time submissions for all quality/ safety related changes for assigned projects.
Preparation and submission of translated texts to EU/Non-EU countries Update of databases and systems for all products (in-line with current SOPs) Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.
Embrace Xeolas values and behaviour Support the Xeolas business by participating in project teams to support departmental initiatives.
On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager.
KEYSKILLS /EXPERIENCE REQUIREMENTS For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy Minimum 4 years of Experience in Regulatory Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions.
Must possess organization skills, time management skills and attention to detail.
Excellent critical thinking and problem-solving abilities.
Strong interpersonal and communication skills Experience in dealing with multiple stakeholders, both internal and external.