Regulatory Affairs Lead Bardi

Regulatory Affairs Lead
Bardi
Emilia Romagna, Bardi

Chaberton Professionals, Management Recruitment division of Chaberton Partners, supports clients in the search and selection of middle and senior management profiles.

We are currently looking for aRegulatory Affairs LeadThe RA Lead will be responsible for ensuring the highest levels of Regulatory control of the business function.

The individual in this position will be responsible for developing, implementing, and maintaining and implementing a comprehensive regulatory strategy in line with the relevant regulations, to safeguard products, streamline operations, and minimise risks. Responsibility:Develop and oversee a robust regulatory strategy in line with all applicable regulations and standards;Establish and manage regulatory submissions and maintain regulatory documentation;Liaise with regulatory authorities and respond to inquiries;Implement regulatory programs, working closely with the Quality (site QP), RD and Operations functions;Interpret and apply regulatory guidelines to business operations; Conduct regulatory Risk Assessments where applicable;Prepare and review regulatory documents and reports;Participate in regulatory inspections and audits;Maintain a regulatory database and track regulatory activities;Ensure that all regulatory activities are documented and archived;Providing input as required on technical matters;Ensure all pharmacovigilance actives are managed and communicated effectively;Collaborate with cross-functional teams to implement security measures, such as surveillance; systems and access controls, to safeguard pharmaceutical inventory;Stay up-to-date with relevant industry regulations, quality standards, and best practices;Ensure that the company's operations comply with all applicable local, national, and international regulations;Provide regulatory training to staff. EDUCATIONAL OR EXPERIENCE REQUIREMENTS:Bachelor's degree in a relevant field; advanced degree (e. g. , MBA, MSc) preferred;Relevant experience (10+ years) in Regulatory Affairs in the pharmaceutical industry.

Knowledge of Medical devices and Italian PMC regulations would be advantageous;Strong understanding of pharmaceutical regulations and quality standards (GDP, GMP);Proven track record of successfully implementing regulatory strategy and international registrations;Excellent project management, communication, and interpersonal skills;Analytical mindset with the ability to make data-driven decisions. REQUIRED BEHAVIOURS:Flexible/adaptable;Team player;Positive attitude;Self-motivated