Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
19-09-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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