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Regulatory Compliance Specialist

2 weeks ago


Cork, Cork, Ireland beBeeRegulatory Full time
Job Summary:

We are seeking a skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for preparing and submitting new marketing authorization applications, maintaining approved marketing authorisation dossiers, and ensuring compliance with regulatory requirements.

Key Responsibilities:

• Preparation and submission of new marketing authorization applications
• Maintenance of approved marketing authorization dossiers, including submission of variations, renewals, and follow-up measures
• Preparation of responses to queries from regulatory authorities and partner companies
• Publishing of regulatory submissions using relevant software
• Review and approval of product artworks to ensure compliance with the relevant marketing authorization
• Interactions with management and partner companies, and provision of documentation required to support the marketing authorizations they have responsibility for
• Regulatory compliance activities and good manufacturing practice (GMP) documentation (specifications, batch records, etc.)
• Maintenance of wholesale distribution authorization
• Maintenance of regulatory forms, logs, and databases with up-to-date regulatory information
• GMP cognizance and compliance with all necessary elements of process paperwork, including standard operating procedures, system logs, stock control systems, machine logs, process documentation, and specifications
• Responsible at all times for plant and process hygiene within the area of operation
• Vigilance for product or process defects and reporting of same

Requirements:

• Level 7 or Bachelor's degree is required
• Past experience in a similar capacity role is desirable
• Working knowledge of eCTD manager software

What We Offer:

• Excellent remuneration and benefits package
• Career development opportunities within a global organization
• Collaborative and supportive work environment
• Training and development opportunities
• Candidates must be immediately eligible to work in Ireland

Skills:

Regulatory affairs