Regulatory Affairs Specialist
11 ore fa
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.
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
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
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.
-
Regulatory Compliance Specialist
4 settimane fa
Roma, Lazio, Italia STERIS Canada Corporation A tempo pienoJob 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.
-
Regulatory Affairs Specialist
2 settimane fa
Roma, Lazio, Italia Perrigo A tempo pienoAbout 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...
-
Regulatory Affairs CMC Expert
1 settimana fa
Roma, Lazio, Italia EUSA Pharma A tempo pienoJob 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...
-
Regulatory Affairs Expert
2 giorni fa
Roma, Lazio, Italia NonStop Consulting A tempo pienoWe 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...
-
Regulatory Affairs Project Lead
1 mese fa
Roma, Lazio, Italia Perrigo A tempo pienoAbout 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...
-
Regulatory Compliance Specialist
1 mese fa
Roma, Lazio, Italia Amaris A tempo pienoKey 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....
-
Regulatory Document Specialist
2 settimane fa
Roma, Lazio, Italia Trilogy Writing And Consulting A tempo pienoWe 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...
-
Regulatory Documentation Specialist
1 mese fa
Roma, Lazio, Italia Trilogywriting A tempo pienoRegulatory 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...
-
Supply Chain Quality Assurance Specialist
1 settimana fa
Roma, Lazio, Italia Randstad Italia Spa A tempo pienoJob 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 pienoAt 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...
-
Regulatory Compliance Specialist
11 ore fa
Roma, Lazio, Italia Jefferson Wells A tempo pienoAbout 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.
-
Esperto in Normative e Compliance Industriale
3 settimane fa
Roma, Lazio, Italia Randstad Italia Spa A tempo pienoDescriviamo 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...
-
Public Affairs Specialist
1 mese fa
Roma, Lazio, Italia Velux Deutschland Gmbh A tempo pienoAbout 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...
-
Corporate Communications Specialist
11 ore fa
Roma, Lazio, Italia Pharmalex A tempo pienoCompany 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...
-
Regulatory Content Specialist
3 settimane fa
Roma, Lazio, Italia MMS Holdings Inc. A tempo pienoAbout 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.
-
European Legal Affairs Specialist
2 giorni fa
Roma, Lazio, Italia Green Recruitment Company A tempo pienoJob 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...
-
Specialista Affari Regolatori Senior
4 settimane fa
Roma, Lazio, Italia Randstad Italia A tempo pienoRandstad 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...
-
Director of Quality and Regulatory Excellence
3 settimane fa
Santa Palomba-Roma II, Lazio, Italia Kenvue A tempo pienoAbout 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...
-
Regulatory Compliance Specialist, Italy
11 ore fa
Roma, Lazio, Italia Bristol-Myers Squibb A tempo pienoCompany 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,...