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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:
In additon this person will:
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 techniques
Knowledge of Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA Guidelines
Good knowledge in written and oral English
Analytical attitudes
Communicative attitudes
Supportive and flexible attitude, high engagement and self-motivation, demeanor to meet deadlines
Relational attitude
Deep 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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