CMC Services Regulatory Affairs Specialist

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Monza site is looking for a Regulatory Affairs Specialist supporting the RA team in Monza DPD.

The identified candidate will:

• Support and interact with Clients for the registration of Patheon Monza site as manufacturer of sterile medicinal products for commercial/clinical use in the main markets (US, EU and Rest of the World).
• Support Clients in defining the regulatory strategy for Patheon Monza site registration.
• Write and review of CTD Module 3.2.P Drug Product for new Marketing Authorizations, variations and renewals and for Clinical Trials Applications (CTAs).
• Support Clients in answering to Regulatory Authorities Deficiency Letters.

In additon this person will:

• Lead interactions with Legal department and external services for notarization, legalization, translation activities for Rest of the World registrations.
• Guarantee that Patheon Monza site manufacturing processes and testing are performed in compliance with the requirements of Marketing Authorization/CTA.
• Assure that the content of the registration dossier/CTA is acknowledged in Patheon Monza site documentation through change controls' management.
• Issue gap analysis before a Regulatory Authority Prior Approval Inspection/clinical batches batch confirmation and identify if required any appropriate corrective actions interacting with the relevant departments.
• Provide regulatory support to Patheon Monza site in order to guarantee the compliance with legislations (Directives, Regulations, Italian Laws, cGMP, ICH/EMA/FDA Guidelines)/Company's policies.
• Support and participate to Regulatory Authorities inspections.
• Maintain constantly updated Regulatory Affairs department's databases.
• Support to Regulatory Affairs Supervisor and to Regulatory Affairs Manager for the editing of reports requested by the EU Regulatory Affairs function.

Finally the preparation/update of the following document will be part of this position's tasks:

Preparation of applications supporting maintenance of the site manufacturing authorizations held at the competent Regulatory Authorities, the extension of the site manufacturing authorizations, Active Ingredients Import Requests for APIs manufactured in extra-EU countries, Controlled Substances License and of the Category 1 Drug Precursors License and relevant annual reports;

Site Master Files (Italian and English PIC version) update;

US FDA DMF TYPE V update;

Requirements

Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology or Biotechnology.Proven experience (3 years) in a Regulatory Affairs department for a FDA approved pharmaceutical company, preferably manufacturing sterile products.

Expertise in writing/review of CTD Module 3.2.P Drug Product for sterile medicinal products.

Expertise in EU/US and Rest of the World Submissions and in managing of documentation (including interaction with notary for notarizations/legalizations and with internal departments/external suppliers)Standard knowledge of pharmaceutical technology and of analytical techniquesKnowledge of Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA Guidelines

Good knowledge in written and oral EnglishAnalytical attitudesCommunicative attitudesSupportive and flexible attitude, high engagement and self-motivation, demeanor to meet deadlinesRelational attitudeDeep emotional intelligence

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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