Regulatory Manager
1 mese fa
When our values align, there's no limit to what we can achieve.
Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.
As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.
Primary Tasks & Responsibilities:
Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
Assess change controls and provide regulatory assessments of quality changes in production and quality control.
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Experience and Knowledge Requirements:
University-level education, preferably in Life Sciences, or equivalent by experience.
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
Strong understanding of CMC and post-approval regulatory requirements.
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
Knowledge of biological processes.
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
Team spirit, flexibility, accountability, and organizational skills.
Fluent in English (written and spoken). French, Italian and German would be a strong plus.
-
Regulatory Affairs Manager
1 mese fa
Milan, Italia PharmaLex A tempo pienoYour Job Prepare, submit and gain approval for regulatory applications to AIFA (MAA, renewal, variations). Assess and respond to regulatory questions to resolve issues. Management of post-approval activities as required. Review and submission (where applicable) of promotional and non-promotional materials. Strategic and operational customer support...
-
Milan, Italia IQVIA A tempo pienoPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
European Regulatory CMC Manager
6 giorni fa
Milan, Italia Hays A tempo pienoLa tua nuova azienda Il nostro cliente è una realtà multinazionale che produce e commercializza prodotti farmaceutici generici. Il tuo nuovo ruolo In ottica dell’ampliamento dell’organico, siamo alla ricerca di una figura di European Regulatory CMC ManagerLa risorsa risponderà direttamente al General Director e si occuperà degli aspetti legati alla...
-
Regulatory Affairs Specialist
3 settimane fa
Milan, Italia AstraZeneca A tempo pienoRegulatory Affairs Specialist (maternity leave) At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As Regulatory Affairs Specialist (maternity leave) in...
-
Regulatory Affairs Specialist
1 mese fa
Milan, Italia AstraZeneca A tempo pienoRegulatory Affairs Specialist (maternity leave) At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As Regulatory Affairs Specialist (maternity leave) in...
-
Regulatory Affairs Specialist
7 giorni fa
Milan, Italia Lights on Women (LoW) A tempo pienoPROFILE:The resource will deal with the analysis of the content of the Authority’s provisions, also for aspects relating to the evolution of the regulatory context within the EU, ensuring the relevant communication within the company, ensuring their correct interpretation and supporting the company functionsfrom time to time involved in the assessment of...
-
Regulatory Affairs Manager
1 mese fa
Milan, Italia IQVIA A tempo pienoThe Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...
-
Regulatory Affairs Specialist
1 mese fa
Milan, Italia Page Personnel A tempo pienoRicerchiamo una figura di Regulatory Affairs Specialist che, a diretto riporto del Regulatory Affairs Manager si occuperà nel dettaglio di:Contribuire alla redazione e gestione di dossier di medicinali ai fini all'ottenimento di autorizzazioni all'immissione in commercio (m1-m5) in Paesi EU/extra EU;Predisposizione delle risposte alle Deficiency Letters da...
-
Milan, Italia Intesa Sanpaolo Group A tempo pienoIntesa Sanpaolo Group Intesa Sanpaolo è un gruppo bancario internazionale, leader in Italia e fra i primi 5 gruppi dell'area euro con oltre 20 milioni di clienti in Italia e all’estero. Estremamente innovativo è anche motore di crescita sostenibile e inclusiva, con impatto concreto sulla società e con un forte impegno per l’ambiente. Scopo e...
-
Regulatory and Start Up Specialist 2
2 settimane fa
Milan, Italia IQVIA A tempo pienoJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions....
-
Treasury Manager
7 giorni fa
Milan, Italia Sonnedix A tempo pienoVacancy Name Treasury Manager - Italy (Milan)Locations MilanLocation Country ItalyProfileLocal Language Job Description-Dont UseShort Description for Portal Treasury Manager reports to the Financial Controller, and in close contact with the Project Finance team, the candidate will be responsible for managing banking relationships and ensuring all loan...
-
Construction Project Manager
7 giorni fa
Milan, Italia Leap29 A tempo pienoConstruction Project Manager - C&I Solar (Italy) Leap29 are seeking a dynamic and results-oriented Construction Project Manager to lead efforts in the Italian renewable energy market, specifically focusing on Commercial and Industrial (C&I) solar projects. My client is a prominent player in the energy transition, dedicated to driving sustainable solutions...
-
Manager – Insurance – Risk
3 giorni fa
Milan, Italia TNP Consultants A tempo pienoJoiningTNP’s Financial Services team, you will collaborate with the Top Management and/or the operational departments (Risk Management, Compliance, Internal Audit, Finance, Commercial Department, Investments, etc.) of main Insurance market players in their strategic and business transformation projects. WHO WE AREBased inMilan,TNP Italiais a consulting...
-
064 - Medtech Manager
7 giorni fa
Milan, Italia Groupe ProductLife A tempo pienoWe are looking for aMedtech Managerto join our team. Location : Italy, Spain, Greece or Portugal Business travel to be planned with clients. ResponsibilitiesThe Medtech Manager will support the team on : Quality & Regulatory Technical Expertise Carrying out also activities as project management , reporting and team coordination EducationTechnical Background...
-
Value & Access Senior Manager
1 mese fa
Milan, Italia Jefferson Wells A tempo pienoOn behalf of an important Biotech company, we are looking for aValue&Access Senior ManagerThe Value and Access Sr Manager is accountable to contribute to the pricing strategy at national level, implement the product value proposition, support for formulary inclusion at regional and hospital level and support the projects implementation within the V&A team....
-
Milan, Italia MET Group A tempo pienoJob Description Primary Objective KMR is developing and constructing a 1 GW, geographically and technologically diversified, portfolio of solar PV, onshore wind, and storage renewable energy assets. KMR´s current portfolio comprises six Italian mid-stage development solar PV projects totalling c. MWp. Main responsibilities We are looking for...
-
Milan, Italia Intesa Sanpaolo Group A tempo pienoIntesa Sanpaolo Group Intesa Sanpaolo è un gruppo bancario internazionale, leader in Italia e fra i primi 5 gruppi dell'area euro con oltre 20 milioni di clienti in Italia e all’estero. Estremamente innovativo è anche motore di crescita sostenibile e inclusiva, con impatto concreto sulla società e con un forte impegno per l’ambiente. Scopo e...
-
Junior Test
1 mese fa
Milan, Italia Intesa Sanpaolo Group A tempo pienoIntesa Sanpaolo Group Intesa Sanpaolo è un gruppo bancario internazionale, leader in Italia e fra i primi 5 gruppi dell'area euro con oltre 20 milioni di clienti in Italia e all’estero. Estremamente innovativo è anche motore di crescita sostenibile e inclusiva, con impatto concreto sulla società e con un forte impegno per l’ambiente. Scopo e...
-
Mergers and Acquisitions Manager
7 giorni fa
Milan, Italia Green Recruitment Company A tempo pienoThe Green Recruitment Company are delighted to have partnered with a leading Renewable Energy Developer which is looking for a Mergers and Acquisitions Manager in Milan. As a Mergers and Acquisitions Manager with a leading Renewable Energy Developer based in Milan, you will be responsible for driving the company's growth through strategic mergers,...
-
Training Manager
2 giorni fa
Milan, Italia TAG Heuer A tempo pienoTAG Heuer:the Swiss Avant-Garde watchmaker since 1860. Avant-garde is our culture and philosophy. Our unique heritage is built on a disruptive mindset, an innovative approach, and a cool and free-minded spirit to think ahead and establish records. The TAG Heuer watches, and chronographs are an authentic concentration of innovation, design and engineering for...
