Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 MIASubmit 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!