Senior Regulatory Affairs Officer - Compliance

On behalf of our client, a leading global pharmaceutical company, we are currently recruiting for a Senior Regulatory Officer Submissions. This is a permanent, full-time role.

Main Objective of Role

• All general RA activities as per RA Officer Compliance job specification e.g.:

• Manage new applications, variations and maintenance of International MA’s
• Gap analysis and remediation of International CMC documentation
• Build and develop International regulatory strategy and regulatory intelligence
• Collaboration with stakeholders to support active MA’s and related activities
• In addition to items outlined below

• Lead by example in completing tasks and interacting with colleagues and stakeholders
• Team mentoring and training
• Continuous development awareness

Other activities as assigned by Team Leader / Manager / Head

Job Duties

SENIOR  OFFICER EXPECTATIONS

• Lead project teams or working groups as directed by management
• Provide mentoring and support for new starters and less experienced team members
• Representing RA Compliance at relevant meetings / telecons / WebExs
• Lead by example to ensure tasks are completed in a timely and effective manner
• Lead by example by displaying ownership and taking accountability for assigned activities
• Proactive identification and reporting of potential issues to management
• Ongoing process and systems assessment to enable continuous development
• Develop / deliver training as appropriate
• Contribute to the development and implementation of RA policies, processes, SOPs and other

DOSSIER MANAGEMENT

• As per RA Officer Compliance job specification
• Peer review of dossier documents for accuracy, completeness and compliance
• Oversee dossier build timelines for any assigned team projects
• Timely escalation of issues causing delays with dossier development

REGISTRATION PROCESS

• Assist RO’s with managing risks and evolving timelines, and with remediation of issues

PERSONAL DEVELOPMENT

• Identify and communicate perceived key strengths to management in order to work more effectively and assist manager with smart project planning

Minimum Skills / Experience:

• Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
• Minimum 3 years experience in a regulatory affairs environment
• Relevant experience in, and general knowledge of, the pharmaceutical industry
• Knowledge of EU and other regions current registration and dossier  requirements
• Knowledge and ability to source International registration requirement information
• Excellent computer competency e.g. Word, Excel, Access, Powerpoint etc
• Experience with systems and tools specific for RA and pharmaceutical sector

For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671