Thermo Fisher Scientific: Regulatory Affairs and

3 giorni fa


Lazio, Italia Confidenziale A tempo pieno

Ensure site compliance with current pharmacopoeias and with the peculiar ones for specific products (Russia, Canada, ANVISA ) Performs other related duties as assigned (recall, stability, ) Supervise Regulatory Affairs and Site Compliance teamRequired Skills/Abilities Extensive knowledge of applicable government regulations & regulatory affairs. Ability to inform and educate managers and department heads on regulations and polices that require compliance. Excellent written and verbal communication skills. Excellent analytical and problem-solving skills. Excellent strategic planning skills. Strong management and negotiation skills Assertiveness and ability to work under pressure and to successfully handle critical situations. Write and edit technical documents Team spirit and resilience Good English skillsEducation and Experience Bachelor’s degree in Scientific fields Regulatory experience in the industry (5-10 years preferred) Up-to-date knowledge of international and governmental guidelines A master’s degree in regulatory affairs a plus



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