Regulatory Affairs Specialist

Xeolas; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

A prominent pharmaceutical company in Ireland seeks an experienced Regulatory Affairs Specialist in Dublin. The role involves preparing regulatory submissions, maintaining quality dossiers, and ensuring compliance with health authority requirements. The ideal candidate should have at least 5 years of experience and a degree in a relevant field. Strong organizational and communication skills are essential for collaborating with various stakeholders.

Qualifications

• Minimum 5 years of experience in Regulatory Affairs.
• Capable of understanding health authority expectations for pharmaceuticals.

Responsibilities

• Prepare and maintain high-quality regulatory dossiers.
• Submit manufacturing authorisation requests to health authorities.
• Advise management on project status and potential problems.

Skills

Regulatory submission expertise

Organizational skills

Interpersonal skills

Problem-solving abilities

Critical thinking

Education

Masters/Bachelor's degree in Science/Technology/Pharmacy

Job description

Dublin, Ireland - Permanent Full Time Role

Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Specialist as we expand.

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.

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.

Key Skills / 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 5 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.

Apply for this Job

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