Antal International is a Multinational Headhunting Company with more than 140 offices in 40 countries.

Life Science is a Team specialized in profiles with a Scientific and Engineering background in Manufacturing, Production, Engineering, SCM, Research and Development, Medical, Quality and Technical-Commercial in Pharmaceutical, Pharmaceutical Chemistry, Biotech, Chemical, Cosmetic, Medical, Diagnostic, Plastic Rubber, Food sectors.

The Role

Our client is one of the top pharmaceutical consulting company in European & CIS market opening a new branch in Milan, Italy. We are looking for a

Regulatory Affairs Manager

that will be part of the regulatory affairs department and will reports to the Regional RA Director EU.

Essential Responsibilities

• Compile and maintain regulatory documentation databases or systems;
• Coordinate, prepare, or review regulatory submissions for domestic or international projects;
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review;
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures;
• Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies;
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance;
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents;
• Participate in internal or external audits;
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies;
• Ensure that quality standards are met, and submissions meet strict deadlines;
• Provide liaising and negotiating with regulatory authorities;
• Understand, and assist in improvement of department SOPs;
• Train and mentor peers in case processing methodologies, as per regulations and local SOPs.

Education and Experience
 

• Higher education (pharmaceutical, medical);
• Work experience in a similar position at least 3 years;
• Knowledge of the registration process, the requirements of expert organizations and institutions for documentation quality;
• Experience in providing non-assisted MP, MD (optional and preferable) registration;
• Confident PC user, knowledge of MS Office;
• English language - not lower than upper intermediate level.

Location               Milan, Italy

Please send your CV written in English to: [email protected]

Ref: 59525

Applications deemed online will be contacted within 30 days of receipt of the application.

Thanks in advance to all those who want to send us their CV, in case of failure to call, we will consider the professional profile for any future needs.