Regulatory Affairs Expert
13 ore fa
About Flamma spa
">Flamma spa is a leading pharmaceutical company specializing in the development, production, and commercialization of molecules and active pharmaceutical ingredients (APIs). With headquarters in Chignolo d'Isola, Italy, near Milan, Flamma has two production sites in Italy, one in Isso (BG) and one in Bulciago (LC), as well as two international sites in Philadelphia (USA) and Dalian (China). The company also maintains commercial offices in Paris (France) and Boston (USA).
Job Title: Regulatory Affairs Specialist
This role involves supporting the Regulatory Affairs Function in managing, planning, and coordinating assigned activities across Flamma's sites.
Main Responsibilities
- Act in line with received priorities and handle distribution and archiving of corporate documentation for Flamma's sites.
- Maintain up-to-date and aligned dossiers filed at various agencies.
- Collaborate with site functions (R&D, Quality Assurance, Quality Control, Procurement, Intellectual Property, etc.) to transfer information into dossiers and ensure alignment with Flamma's operational activities.
- Ensure notification of main variations to agencies and customers.
- Good knowledge of English, both written and spoken, is required.
Main Activities
- Follow regulatory strategies defined by Flamma's RA Manager, execute plans for developing and implementing new dossiers on national and foreign agencies.
- Proactively protect Flamma's know-how and sensitive data.
- Evaluate gaps between current regulatory guidelines and Flamma's filed dossiers.
- Support during agency or customer compliance audits, aid on-site and remotely.
- Create and control the execution of corporate procedures/policies and updating activities.
- Assist the RA Manager in maintaining Flamma personnel up-to-date on new regulatory guidelines.
- Prepare and ensure correct compilation and availability of documentation required by agencies.
- Cooperate in answering questions from agencies and customers.
- Contribute to training Flamma personnel in Regulatory Affairs skills and competences.
- Participate in internal and external training organized by the company.
- Ensure application and compliance with company procedures regarding Organizational Model Legislative Decree no. 231/01 (applicable to the Italian territory).
- Effectively apply procedures related to Regulatory, Quality, Safety, and Environment.
- Carry out activities correctly using personal protective equipment (PPE) and specific tools/instruments assigned.
Requirements
A degree in Chemistry or CTF or Pharmacy; preferred experience (2-3 years) in API manufacturing within a Regulatory Department.
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