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CORPORATE REGULATORY AFFAIRS SPECIALIST
2 settimane fa
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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