Senior Regulatory Affairs CMC Specialist

Senior Regulatory Affairs CMC Specialist

Recordati

Milan, Italy

Job Purpose

We are looking for a Senior Regulatory Affairs CMC Specialist who has consolidated experience on Chemistry, Manufacturing and Control (CMC) aspects in order to manage the preparation of dossiers for submission to regulatory authorities worldwide.

Key Responsibilities

• Writing and managing technical sections of Module 3 in collaboration with relevant departments/functions
• Assessment of documentary/technical gaps associated with existing products, processes and methods (Gap Analysis)
• Evaluation of technical reports (Process Validation Protocols & Reports, Analytical Methods Validation, AMT, Development Reports, TT)
• Competence on how to translate technical reports into regulatory documents suitable for submission to the Regulatory Authorities
• Assessment of Modules 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variations
• Develop, plan and execute appropriate regulatory strategies in close collaboration with the regulatory sub-functions, Industrial operations and CMC team members
• Conduct regulatory assessments for CMC change controls
• Participation as an active member of cross-functional teams for technology transfers, complex CMC lifecycle projects

Required Education

• Degree of chemistry, pharmacist or biotechnology

Required Skills and Experience

• 7+ years working experience in CMC regulatory affairs
• The profile sought is a Specialist in the Regulatory CMC sector with an extremely technical cut who has previous business experience (eg manufacturing Compliance, Regulatory CMC)
• Previous experience in the management of tech transfers from a RA CMC perspective is strongly recommended
• The resource must have adequate skills to understand and deal with the "intelligent and targeted" writing of a section of Module 3 in order to place in it the correct information expected by Regulatory Authorities. The resource must know the guidelines governing the CMC sector, such as GMP, ICH Q, EMA Quality guidelines, WHO guidelines and must be able to interpret these guidelines according to the product to be managed

Technical Competencies

• Analytical chemistry/CTD/manufacturing environment/medical devices/GMP/ICH – Regulatory guidelines/Eur. Ph. /technical transfers

Required Behaviours and Competencies

• Positive thinking and behaviour
• Effective presentation and communication skills
• Skilled in time management and able to meet deadlines
• Initiatives and self-motivation abilities

Required Languages

• Fluent in English