Regulatory Affairs Specialist

11 ore fa


Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno

Job Title: Regulatory Affairs Specialist

Meditrial Europe Ltd. is seeking an experienced Regulatory Affairs Specialist to oversee the regulation process for products requiring governmental approval in the lifescience industry, specifically pharma and medtech.

Job Summary

The successful candidate will be responsible for ensuring compliance with regulatory requirements, managing CTD submissions, and collaborating with subject matter experts on strategic regulatory strategies.

Responsibilities
  • Manage the preparation and submission of CTDs (Electronic Common Technical Documents)
  • Collaborate with cross-functional teams on the implementation of regulatory strategies for new product approvals
  • Prepare and submit variations, renewals, and safety-related documents to regulatory authorities
  • Ensure regulatory compliance through effective management of quality systems and processes
  • Liaise with manufacturers and internal stakeholders to ensure seamless communication
  • Support the development and maintenance of technical files and recall procedures
  • Review and submit promotional materials for compliance
  • Assist with clinical investigation management and medical device post-marketing surveillance activities
Requirements

We are looking for a highly motivated individual with:

  • A Master's Degree in a scientific field or equivalent experience in life science and regulatory affairs
  • Excellent knowledge of regulatory frameworks and procedures in the lifescience industry
  • Strong analytical, problem-solving, and communication skills
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint) and ability to learn new software
  • Demonstrated ability to handle multiple competing priorities and work effectively in a team environment
About Us

Meditrial Europe Ltd. is a leading provider of innovative solutions in the lifescience industry. We offer a dynamic and supportive work environment, competitive salary, and opportunities for growth and development.

Salary

€60,000 - €80,000 per annum depending on experience.



  • Roma, Lazio, Italia STERIS Canada Corporation A tempo pieno

    Job OverviewWe are seeking a Regulatory Compliance Specialist to join our team in Pomezia, Italy. As a key member of the STERIS Regulatory Affairs function, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the European market.


  • Roma, Lazio, Italia Perrigo A tempo pieno

    About PerrigoPerrigo is a top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over-the-counter and infant formula.We are proud to be part of the self-care industry, providing trusted health and wellness solutions accessible to all.In this role, you will be responsible for ensuring regulatory compliance and...


  • Roma, Lazio, Italia EUSA Pharma A tempo pieno

    Job Overview:We are seeking a seasoned Regulatory Affairs CMC Specialist to join our team at EUSA Pharma.About the Role:The ideal candidate will possess consolidated experience in Chemistry, Manufacturing and Control (CMC) aspects to manage the preparation of dossiers for submission to regulatory authorities worldwide.Key Responsibilities:Technical Section...


  • Roma, Lazio, Italia NonStop Consulting A tempo pieno

    We are seeking a highly skilled Regulatory Affairs Expert to join our team at NonStop Consulting in Italy. This exciting opportunity combines national responsibility with a regional perspective, allowing you to make a real impact in the agricultural sector by facilitating the availability of cutting-edge crop protection solutions.About the RoleThis role is...


  • Roma, Lazio, Italia Perrigo A tempo pieno

    About PerrigoPerrigo is a leading player in the European Consumer Self-Care market and the largest U.S. store brand provider of over-the-counter and infant formula. Our mission is to enhance the wellbeing of our colleagues and consumers alike by providing The Best Self-Care for Everyone.We pride ourselves on fostering an inclusive, collaborative culture...


  • Roma, Lazio, Italia Amaris A tempo pieno

    Key Responsibilities:As a Regulatory Affairs Specialist at Amaris Consulting, you will play a crucial role in ensuring alignment with business strategies and regulatory requirements. Your duties will include managing the registration process, negotiating with regulatory authorities, and implementing new regulations within specified legal deadlines....


  • Roma, Lazio, Italia Trilogy Writing And Consulting A tempo pieno

    We are seeking a highly skilled Regulatory Document Specialist, or Senior/Principal Medical Writer, to join our team at Trilogy Writing & Consulting. As a key member of our clinical development team, you will be responsible for producing high-quality regulatory documents that meet the requirements of our clients in the international pharmaceutical...


  • Roma, Lazio, Italia Trilogywriting A tempo pieno

    Regulatory Documentation Specialist RoleTrilogy Writing & Consulting, an Indegene Company, is currently seeking a highly skilled Regulatory Documentation Specialist to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry.As a key member of our team, you will be integral to the writing...


  • Roma, Lazio, Italia Randstad Italia Spa A tempo pieno

    Job DescriptionWe are seeking a highly skilled Supply Chain Quality Assurance Specialist to join our team at Randstad Italia Spa in Rome. The ideal candidate will have a strong background in quality assurance and a deep understanding of GMP regulations.Key ResponsibilitiesProvide quality assurance management of key contractors for Pfizer, ensuring compliance...


  • Roma, Lazio, Italia Novo Nordisk A tempo pieno

    **Job Overview**We are seeking a highly experienced Regulatory and Pharmacovigilance Lead to join our team in Rome, Italy. As a key member of our Clinical, Medical and Regulatory (CMR) department, you will be responsible for guiding the Regulatory and Pharmacovigilance team and ensuring compliance with corporate and legal requirements.**About the Role**The...


  • Roma, Lazio, Italia Parexel A tempo pieno

    At Parexel, we're driven by a shared purpose - to improve global health outcomes. Our commitment to excellence in clinical development solutions is underpinned by our passion for making a difference.We seek a seasoned Regional Regulatory Affairs Director (EMEA) with extensive expertise in CMC regulations. As a key member of our team, you'll be responsible...


  • Roma, Lazio, Italia Jefferson Wells A tempo pieno

    About the RoleAt Jefferson Wells, we are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for ensuring high-quality content in regulatory CMC documentation, aligning with applicable guidelines for new and approved Drug Products and/or Drug Substances in Europe, USA, and other countries.


  • Roma, Lazio, Italia Randstad Italia Spa A tempo pieno

    Descriviamo l'opportunità di un Regulatory Affairs Specialist II presso una multinazionale del settore chimico farmaceutico. Questa posizione offre la possibilità di lavorare in un team dinamico con un contratto di somministrazione a tempo determinato.Responsabilità:Scrivere ed esaminare dossier normativi per garantire gli standard correnti;Verificare la...


  • Roma, Lazio, Italia Velux Deutschland Gmbh A tempo pieno

    About the RoleWe are seeking a skilled Public Affairs Manager to join our External Relations & Sustainability department in Belgium. As a key member of our team, you will be responsible for developing and executing a public affairs strategy focusing on energy efficiency, environmental issues, and good indoor climate of buildings.Key ResponsibilitiesDevelop...


  • Roma, Lazio, Italia Pharmalex A tempo pieno

    Company OverviewPharmaLex is a leading service provider for the pharmaceutical, biotech, and medical device industries globally. As part of Cencora, we offer comprehensive solutions to effectively design regulatory needs, from early development to product maintenance activities. Job Title: Corporate Communications SpecialistEstimated Salary: 60,000 - 80,000...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    About MMS Holdings Inc.MMS is an innovative, data-focused Contract Research Organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with a proven scientific approach to complex trial data and regulatory submission challenges.


  • Roma, Lazio, Italia Green Recruitment Company A tempo pieno

    Job Overview:The Green Recruitment Company is seeking an experienced and skilled European Legal Affairs Specialist to join our team. As a key member of the company, you will play a crucial role in overseeing all group legal and compliance activities for our European operations.About the Role:We are looking for a highly organized and self-motivated individual...


  • Roma, Lazio, Italia Randstad Italia A tempo pieno

    Randstad Italia è una società leader nel settore del lavoro temporaneo e della gestione delle risorse umane. Siamo alla ricerca di un Specialista Affari Regolatori per coprire il ruolo di Regulatory Affairs Specialist II presso una importante azienda multinazionale del settore chimico farmaceutico. La durata del contratto è prevista per 6 mesi, durante i...


  • Santa Palomba-Roma II, Lazio, Italia Kenvue A tempo pieno

    About KenvueWe are a leading company in the FMCG, Chemical, Automotive, and Healthcare industries.Job DescriptionAs Director of Quality and Regulatory Excellence, you will lead our efforts to ensure compliance with ISO standards (9001 and 13485) and cosmetic legislation.ResponsibilitiesDevelop and implement quality management systems to meet regulatory...


  • Roma, Lazio, Italia Bristol-Myers Squibb A tempo pieno

    Company OverviewBristol Myers Squibb is a multinational biotechnology company dedicated to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.About the RoleWe are currently seeking an experienced Regulatory Compliance Specialist to join our team in Italy. As a key member of our compliance function,...