Regulatory Affairs Manager

Whatjobs; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical firm in Milan is seeking a Regulatory Affairs Manager responsible for ensuring compliance with regulations and managing product registrations. The ideal candidate has a Bachelor's in Life Sciences and at least 5 years of experience in the regulatory field, preferably in the pharmaceutical industry. Excellent communication skills and the ability to work under pressure are essential. Fluent English is required, and proficiency in another European language is a plus.

Competenze

• Minimum 5 years of experience in the regulatory field within the pharmaceutical industry.
• Knowledge of medicines legislation, GMP, and reference guidelines.
• Experience with AIFA and AGES preferred.

Mansioni

• Manage the registration of pharmaceutical products and medical devices.
• Support maintenance of regulatory files and tracking databases.
• Provide regulatory expertise for new product development.
• Assist in reviewing documentation for compliance.
• Act as a liaison between project teams.
• Communicate design changes to existing products.
• Plan and develop product trials and interpret data.
• Stay updated with the latest regulatory rules.
• Give presentations to regulatory authorities.
• Write standard operating procedures for regulatory affairs.
• Coordinate local compliance activities.

Conoscenze

Good communication skills

Team working

Critical thinking

Planning

Meeting deadlines efficiently

Working under pressure

Fluency in English

Fluency in another European language

Formazione

Bachelor Degree in Life Science

Specialisation in Regulatory Affairs

Descrizione del lavoro

Mission

Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.

Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant government legislation, and that patient safety and efficacy are at the forefront of business activities. Act as the critical liaison between their organisation, the products they sell and the regulatory authorities by applying their scientific, business and regulatory expertise.

Main activities

• Manage the registration of pharmaceutical products, as well as medical devices and API in your countries and regions.
• Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
• Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation
• Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines
• Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
• Communicate design changes to existing products and company practices where necessary
• Plan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvals
• Stay up to date with the latest rules and regulations
• Give presentations to regulatory authorities
• Write appropriate standard harmonised regulatory affairs operating procedures for the company
• Coordinate local compliance activities: impact assessment on local Change Control, define the local regulatory strategy for drug product communications, in compliance with local regulation.

Requirements

• Bachelor Degree in Life Science disciplines, preferably in Pharmacy / CTF / Biological Sciences / Chemistry. A specialisation in Regulatory Affairs is a plus.
• At least 5 years experience in regulatory field within pharmaceutical industry, preferably in companies with manufacturing sites for medical products
• Knowledge of medicines legislation, GMP and reference guidelines.
• Experience with AIFA and AGES is prefered.
• Experience in using the various applications of the AIFA portal.
• Good communication skills – both written and verbal
• Skills of team working, critical thinking and planning, meeting deadlines efficiently.
• The ability to work under pressure and to tight deadlines
• Fluent in both spoken and written English. Fluency in another major European language is preferred.