Regulatory Affairs Specialist

1 settimana fa

Pisa, Italia Regulatory Pharma Net A tempo pieno

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**What will you deal with**:
Prepares the regulatory documentations for development programs (IMPDs/INDs, IB, CTA forms, Scientific Advice/Protocol Assistance Briefing Document, Orphan Drug Designation submission package).
Performs the gap analysis of technical documents versus module 3 and the evaluation of regulatory variations to update the regulatory dossiers - update of Module 3.
Performs elemental Impurities Risk assessments and environmental risk Assessments.
Ensures consistency, completeness, accuracy and adherence to regulations and applicable guidelines and to the client’s need for all regulatory submissions.
Provides assistance during the procedures for the preparation of response documents.
Identifies and communicates potential risks in submissions and anticipate regulatory responses through scenario planning.
Builds and maintains professional contacts with scientific experts as well as with national and international authorities.
Ensures that project work proceeds according to agreed deadlines through continuous contacts with all the involved parties (CMO, Sponsor ).
Gives assistance during the procedure for preparation of the response document.
Gives support to the Client in the critical evaluation of the appropriate regulatory strategy.
**Essential requirements**:
Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
**Soft Skills**:
Communication and teamwork.
Attention to detail and organizational skills.
Time management and problem-solving.
Adaptability and resilience.

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