Corporate Regulatory Affairs Specialist

2 mesi fa

Milano, Italia Flamma Spa A tempo pieno

Flamma Group è un'azienda specializzata nello sviluppo, produzione e commercializzazione di molecole e principi attivi (API) per l'industria farmaceutica.
Con Headquarter a Chignolo d'Isola, vicino a Milano, Flamma vanta altri due stabilimenti produttivi in Italia, ad Isso (BG) e Bulciago (LC) e due stabilimenti all'estero, a Philadelphia (USA) e Dalian (Cina).
E' presente inoltre con uffici commerciali a Parigi (Francia) e Boston (USA).
CORPORATE REGULATORY AFFAIRS SPECIALIST - sostituzione maternità Scope Support Regulatory Affair Function in managing, planning and coordinating the assigned Regulatory Affairs activities of the Flamma's sites.
Main Responsibilities Act in line with the received priorities, take care of distribution and archiving of the corporate documentation for the Flamma's sites.
Cooperate in keeping up to date and aligned the Dossiers filed at the different Agencies.
Cooperate with site's Functions (R&D, Quality Assurance, Quality Control, Procurement, Intellectual property, etc) for the correct transfer of any information into the Dossiers; is engaged in preparation and in maintaining the alignment of Dossier filed to the Authorities with Flamma's Sites operative activities.
Assure the notification of main variations to Agencies and Customer.
Good knowledge of English, both written and spoken, is required.
Main Activities Follow the Regulatory Strategies as defined by Flamma RA Manager, execute Regulatory plans for the development and implementation of new Dossiers on national and Foreign Agencies.
Proactively act for the protection of Flamma's know-how and sensitive data.
Perform the gap evaluation between current Regulatory guidelines and Flamma's filed Dossiers.
Act as support during both Agency or Customer Compliance audits, aid on site and in remote.
Create and control the execution of corporate procedure/policies and the updating activities.
Help the RA Manager in maintaining Flamma's personnel up to date on new regulatory guidelines.
Prepare, for the part of competence, and ensure the correct compilation and availability of the documentation required by Agencies.
Cooperate in answering questions received from Agencies and Customers.
Cooperate in the training of Flamma's personnel for the development of their skills and competences on Regulatory Affairs.
Participate in internal and external training organized by the company.
Ensure the application and compliance with company procedures, with reference to the Organizational Model Legislative Decree no.
231/01 (referring to actions executed on the Italian territory).
Effectively apply the procedures relating to Regulatory, Quality, Safety and the Environment.
Carry out the activities correctly using the PPEs and any specific tool or instrument assigned.
Requirements: Degree in Chemistry or CTF or Pharmacy; Preferred experience (2-3 years) in API Manufacturer sector inside Regulatory Department.
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