Corporate Drug Regulatory Affairs Manager

Project details

• Start: flexible
• Location: Dublin, IE

A Corporate Drug Regulatory Affairs Manager

Role of this position

JOB REQUIREMENTS

Please call Tom Devaney for further information on [contact removed] or email: [contact removed]

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities.

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• on a 12-Month Temp Contract
• is required by CareerWise Recruitment for our client BASED in North Dublin. The Manager of Corporate Drug Regulatory Affairs serves as the vital link between the company and global health authorities to ensure medicines are safely and legally brought to market. This corporate leadership role oversees the planning, preparation, and submission of global marketing authorization applications while managing lifecycle variations to maintain product compliance worldwide. HYBRID
• 3 days per week on-site, must have Minimum Stamp 4!!
• Handling of marketing authorisation application procedures (e.g. new submissions, line extensions) worldwide, as well as registration maintenance activities (e.g. variations, renewals)
• Preparation and discussion of licensing strategies with national and international authorities
• Collaboration in regional / global projects in Cross functional teams
• Review, preparation, coordination and processing of regulatory documents (CTD-module 1)
• Review and coordination of quality documentation (CTD – module 3 / 2.3)
• Coordination of clinical and non-clinical documentation
• Support of QA activities (e.g. change control, PQR), drug information and
• pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs)
• Use of electronic systems like Documenten management system, Change Control System, Regulatory Information Management System, etc.
• University degree in natural sciences, i.e. Biology, Chemistry or Pharmacy
• Knowledge of essential regulatory requirements
• Ability to plan and execute regulatory projects globally
• Excellent communication skills, a real team player
• Excellent skills in English language
• Knowledge of standard EDV programs (e.g. MS-Office)
• Preferable knowledge in common regulatory systems (e.g. DMS, CCS, RIMS)