Regulatory Affairs Expert

13 ore fa


Milano, Lombardia, Italia Flamma spa A tempo pieno

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.



  • Milano, Lombardia, Italia Pfizer, S.A. de C.V A tempo pieno

    Job Description:Pfizer, S.A. de C.V seeks a skilled Regulatory Affairs Expert to support the development and approval of innovative medicines. The ideal candidate will possess in-depth knowledge of global regulatory environments, with a focus on EU regulations. Key responsibilities include providing strategic regulatory guidance, leading/co-leading projects,...


  • Milano, Lombardia, Italia Hover Senior Living Community A tempo pieno

    Job SummaryThe Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and corporate policies.The Regulatory Affairs Senior Specialist supports interactions with the national Regulatory Authorities, i.e....


  • Milano, Lombardia, Italia Healthcare Businesswomen'S Association A tempo pieno

    Healthcare Businesswomen'S Association is a leader in the Generic and Biosimilar medicines sector, touching the lives of almost 500 million patients annually. We're now seeking a skilled Regulatory Affairs Specialist to join our team and play a crucial role in shaping the future of our organization.**Job Summary:**We are looking for an experienced Regulatory...


  • Milano, Lombardia, Italia The Kraft Heinz Company A tempo pieno

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Milan. As an expert in regulatory affairs, you will play a crucial role in ensuring compliance with food legislation and government guidelines.About the RoleYou will be responsible for reviewing and approving label artwork to ensure it meets legislative...


  • Milano, Lombardia, Italia Recordati A tempo pieno

    Job DescriptionRecordati is seeking a highly skilled Regulatory Affairs Specialist to join its international team. As a key member of the Corporate Regulatory Affairs department, you will be responsible for the management of regulatory activities for medicinal products for human use.Key Responsibilities:Preparation, review, and submission of relevant...


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Pfizer is a Patient-Centric CompanyWe're looking to bring medicines to the world faster, and we're not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential, and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    About the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Page Personnel.


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Page Personnel is seeking a highly skilled Regulatory Affairs Specialist to play a key role in ensuring compliance with regulatory requirements for our medical devices. The ideal candidate will have a strong understanding of FDA regulations, EU Medical Device Regulation (MDR), and international regulatory requirements for medical devices.About the RoleWe are...


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Pfizer is seeking a highly skilled Regulatory Affairs Specialist to join our team in the Early Phase, Oncology department. This role will provide strategic expertise and leadership in EU regulatory strategies for designated early-stage oncology portfolio projects/products.**Job Summary:**The successful candidate will be responsible for representing Pfizer's...


  • Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

    Job Title:Senior Regulatory Affairs Director - Medical Device Lifecycle ManagementLocation:Italy (Milan) – HybridAbout the Role:This is an exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to increasing growth, the business is looking for an Associate...


  • Milano, Lombardia, Italia Reckitt A tempo pieno

    About the RoleAs a Regulatory Assistant, you will be at the forefront of our innovation and compliance efforts. You will jumpstart your career in a role that provides a blend of strategic thinking and hands-on experience within a dynamic, collaborative environment.We are seeking a highly motivated and detail-oriented individual to join our Regulatory team....


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our team in the early-phase oncology portfolio. This role will play a crucial part in ensuring regulatory compliance and advancing the development of new cancer treatments.


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    **About the Role**Pfizer is seeking a highly skilled Regulatory Affairs Professional to join our team in the Early Phase Oncology department. This role will be responsible for ensuring timely submissions and approvals in the EU region, as well as providing regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).Key...


  • Milano, Lombardia, Italia 0896 Deutsche Bank Società per Azioni A tempo pieno

    Deutsche Bank Societa per Azioni is seeking a highly skilled Compliance and Regulatory Affairs Manager to join its team in Italy. The ideal candidate will have strong expertise in compliance, regulatory affairs, and risk management.Job Description:The successful candidate will be responsible for managing interactions with local and global regulators,...


  • Milano, Lombardia, Italia Randstad Italia spa A tempo pieno

    Ricerche per un Regulatory Operations Specialist presso Randstad Italia spa.Descrizione del lavoroLa nostra azienda, Randstad Italia spa, è alla ricerca di un Regulatory Operations Specialist per sostenere il nostro team di Regulatory Affairs.Il candidato ideale dovrà essere in grado di assicurare la gestione dei cambiamenti regolatori, comprese le...


  • Milano, Lombardia, Italia Randstad Italia Spa A tempo pieno

    Company OverviewRandstad Italia Spa is a leading staffing agency providing innovative workforce solutions. We are dedicated to connecting talented professionals with top employers.SalaryThe estimated salary for this position is €55,000 - €65,000 per annum, depending on experience and qualifications.Job DescriptionWe are seeking a highly skilled...


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Senior Associate, Early Phase, Regulatory AffairsJob SummaryRepresent the EU region (EU, UK, CH, NZ, AUS) in regulatory sciences for early-stage oncology portfolios.Contribute strategic expertise to the Global Regulatory Strategic Team (GRST).Develop and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and...


  • Milano, Lombardia, Italia Ipsen Spa A tempo pieno

    About the RoleWe are seeking an experienced Head of Medical and Regulatory Affairs to lead our medical and regulatory affairs activities in Italy. As a key member of our leadership team, you will be responsible for ensuring that all medical and scientific support activities are conducted with the highest level of quality and compliance.Key...


  • Milano, Lombardia, Italia Randstad A tempo pieno

    Randstad Inhouse Services is partnering with Pfizer to find a Regulatory Operations Specialist to support their specialty Pharma team. The ideal candidate will be responsible for managing regulatory change activities, reviewing and approving changes, and providing support for the closure of deficiency letters and regulatory requests.Key...


  • Milano, Lombardia, Italia Randstad Italia spa A tempo pieno

    At Randstad Italia spa, we are seeking a skilled Contractor Regulatory Operations Associate to join our team. This is a fantastic opportunity to work with a leading company in the pharma industry.About the RoleThis role will involve working closely with the regulatory team at Pfizer srl to manage regulatory change activities for products manufactured by...