Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

Collaborate with Thermo Fisher Scientific Inc. a global leader in scientific services. As a Regulatory Affairs Specialist in Monza help register sterile medicinal products for markets worldwide.

Responsibilities

• Support and collaborate with clients to define regulatory strategies.
• Compose and assess CTD Module 3.2.P Drug Product for new marketing authorizations and clinical trials submissions.
• Assist clients in responding to regulatory authorities deficiency letters and information requests.
• Lead interactions with the Legal department and English translation provider for registrations.
• Ensure manufacturing processes and testing adhere to marketing authorization requirements.
• Handle the content of registration dossiers through change controls.
• Conduct gap analyses before regulatory authority inspections or before product batch confirmation and identify corrective actions.
• Provide regulatory support to ensure compliance with current legislations and company policies.
• Support readiness for regulatory authorities inspections and participate in them.
• Maintain and update regulatory affairs databases meticulously.

Additional Responsibilities

• Manage applications for maintaining and extending Monza site MIA
• Submit notifications to the Italian Health Authority.
• Handle applications for active ingredients manufacturing/import authorizations.
• handle notifications on blood-derived imports to the Italian Health Authority.

Requirements

• Degree in Chemistry and Pharmaceutical Technology Pharmacy Biology or Biotechnology.
• At least 3 years of background in a regulatory affairs division within an FDA-endorsed pharmaceutical firm particularly in the production of sterile items.
• Proficiency in CTD Module 3.2.P Drug Product for sterile medicinal items.
• Knowledge of EU/US and global submissions quality documentation management pharmaceutical technology and analytical techniques.
• Familiarity with Directives Regulations Italian Laws cGMP GMP Annex 1 ICH/EMA/FDA Guidelines.
• Proficiency in written and oral English.
• Strong analytical and communicative skills with an encouraging and flexible demeanor.
• High engagement self-motivation and collaboration skills with deep emotional intelligence.

Join us at Thermo Fisher Scientific where you will play a key role in ensuring our products meet regulatory standards successfully!