- 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 with company set-up activities and with national requirements to market medicinal products in Italy.
- Translations and review of Product Information (Linguistic Review).
- Management of activities related to educational materials.
- Communication with Clients and Health Authorities.
- Project Management, execution of activities, progress monitoring until end of project.
- Advisor to Clients on regulatory procedures and requirements in consultation with senior management.
- Advisor to Clients on strategic issues based on experience and knowledge in consultation with senior management.
- Flexibility to respond to client demands (also outside strict regulatory framework) according to required timelines.
- Travel to client meetings as required or participation in TCs.
- Develop and maintain a thorough knowledge of European and national regulatory requirements.
- Maintain the Company's values and work ethos.
- Participation in archiving activities.
- University degree in pharmacy or other natural sciences
- 7-10 year experience in Regulatory Affairs department
- Solid experience in review and submission of promotional materials and life-cycle management activities with AIFA
- Project management experience
- Good knowledge of EU and national pharmaceutical legislation
- Ability to analyze and solve problems and to offer solutions for a given task or project
- Very high attention to detail
- High service orientation, flexibility, strong sense of responsibility, organizational skills, autonomous approach to work, ability to process parallel projects and tasks, self-motivation
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors, ability to fit in an international and multicultural environment
- Ability to manage internal and external (client) relationships on operational as well as client's team lead level
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- Italian language is a must; Fluent English, both written and spoken
- An opportunity to work within an organisation with a positive work/life balance environment , one of the leading service companies for the Pharmaceutical Industry globally, in which our values are the backbone of our company, i.e. international mindset, growth and learning, collaboration, quality focus, dynamic working approach and integrity and respect.
- The location of the proposed job is Milan (Italy), and smart working may be an option.
-
Regulatory Affairs Senior Manager
23 ore fa
Confidenziale Milano, ItaliaPer conto di una realtà multinazionale farmaceutica con a Milano ricerchiamo un: · Regulatory Affairs Senior ManagerRispondendo direttamente all' Head of Regulatory and Drug Safety, la risorsa avrà le seguenti responsabilità: · Provvede in prima persona o attraverso i propri coll ...
-
International Regulatory Affairs Manager
2 giorni fa
Confidenziale Lombardia, Italia: · Milano office · Specializzazione: · Life science · : · 2 international regulatory affairs manageril profilo selezionato sarà inserito interno del team international regulatory affairs. Le attività principali saranno: · Responsabilità dellintero ciclo di vita per tutte le ques ...
-
Legal Affairs Manager
3 giorni fa
Taylor Root Global Legal Recruitment Milano, ItaliaLegal Affairs Manager · **Location** · Milan**Contract Type** · Permanent**Posted** · Posted 43 mins ago**Industry** · Energy**Salary** · Company car,medical insurance,pension**Expiry Date** · **Legal Affairs Manager Renewable energy sector** · An Italian headquartered start-up o ...
-
Regulatory Affairs Manager
2 giorni fa
ICON Milano, ItaliaAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. · Our 'Own It' culture is driven by four key values that bring us together as individuals ...
-
Regulatory Affairs Manager
1 settimana fa
AGC Biologics Milano, Italia**Agc Biologics, leader company in Cell & Gene Therapy field, is looking for a Regulatory Affairs Manager** · **Main Responsabilities**: · - Support the customers in regulatory dossier filing, including the revision of the CMC documents for regulatory submissions and the answer t ...
-
Adecco Italia Milano, ItaliaAdecco Lifescience, divisione specializzata del gruppo Adecco, ricerca per un'azienda cliente un/a: · REGULATORY AFFAIRS MANAGER Settore MEDICAL DEVICE · La risorsa si occuperà delle seguenti mansioni: · - Supervisione e approvazione protocolli e report di test, di validazioni de ...
-
Medical Affairs Manager Dermatology
23 ore fa
Johnson & Johnson Cologno Monzese, ItaliaPer la sede di Milano, Janssen ricerca un · **MEDICAL AFFAIRS Manager (Dermatology)** · da inserire, a TEMPO INDETERMINATO, a diretto riporto del Therapeutic Area Medical Head nella Direzione Medical Affairs. · **MISSION**: · Progettare ed implementare, nel rispetto delle normati ...
-
Legal Manager, Corporate Affairs
2 giorni fa
FARFETCH Milano, ItaliaNew Guards Group is the home to 10 international luxury brands: Marcelo Burlon County of Milan, Off-White c/o Virgil Abloh, Palm Angels, Unravel Project, Heron Preston, Alanui, Kirin Peggy Gou, Opening Ceremony, Ambush and There Was One. We work with the understanding that fashio ...
-
Reg Affairs Sr Manager
3 giorni fa
Thermo Fisher Scientific Milano, ItaliaAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed ...
-
Medical Affairs Manager
3 giorni fa
Johnson & Johnson Cologno Monzese, ItaliaFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of ou ...
-
Regulatory Affairs Manager
1 settimana fa
ManpowerGroup Bellusco, ItaliaManpower Professional, a division of Manpower Group, dedicated to the search and selection of Middle Management profiles, is looking for an experienced Regulatory Affairs & Quality Specialist, for medium-sized company, COATING INDUSTRY. · The role is responsible for formulating a ...
-
Regulatory Affairs Manager
4 giorni fa
Digitec srl Lecco, ItaliaWe are looking for a **Regulatory Affairs Manager **who will be responsible for formulating and implementing regulatory affairs policies and procedures for our proprietary software medical devices. As Regulatory Affairs Manager you will be reporting directly to R&D Director and l ...
-
Medical Affairs Manager
5 giorni fa
CSL Behring Milan, Italia A tempo pienoTo strengthen our Medical Affairs team in Milan, Italy, we are currently hiring a · Medical Affairs Manager (m/f/x) - Coagulation · (Fulltime / permanent/ Location: Milan) · The Opportunity · You are accountable for the medical strategy and deliverables (i.e. advisory boards/expe ...
-
Medical Affairs Manager
1 settimana fa
CSL Milano, Italia A tempo pienoTo strengthen our Medical Affairs team in Milan, Italy, we are currently hiring a · Medical Affairs Manager (m/f/x) - Coagulation · (Fulltime / permanent/ Location: Milan) · The Opportunity · You are accountable for the medical strategy and deliverables (i.e. advisory boards/e ...
-
Medical Affairs Manager
2 giorni fa
CSL Behring Milano, Italia A tempo pienoTo strengthen our Medical Affairs team in Milan, Italy, we are currently hiring a Medical Affairs Manager (m/f/x) - Coagulation (Fulltime / permanent/ Location: Milan) The Opportunity You are accountable for the medical strategy and deliverables ( advisory boards/expert meeting ...
-
Medical Affairs Senior Manager
5 ore fa
Dompé Milan, ItaliaFor Our Company in Milan (Italy) we are looking for a Medical Affairs Senior Manager within Primary & Specialty Care Bunsiness Unit. · The candidate will work with the Medical Affairs function as a medical scientific connection between Dompé and key external stakeholders to facil ...
-
medical affairs manager coagulation
4 giorni fa
Jefferson Wells Milan, Italia A tempo pienoWe're looking for a Medical Affairs Lead (Coagulation) on behalf of a multinational pharma company (italian HQ: Milan). · The Opportunity · You are accountable for the medical strategy and deliverables (i.e. advisory boards/expert meetings, symposia, publications plan, clinical s ...
-
Contracts and Legal Affairs Manager
4 giorni fa
Mapp Digital Milan, Italia A tempo pienoWHAT YOU WILL DO: · We are seeking a smart, dedicated and detail-oriented Contracts and Legal Affairs Manager to join our fast-paced, start-up like, international legal team. · The successful candidate is a detail-oriented individual who is hands-on, has good communication skil ...
-
Regulatory Affairs
2 ore fa
Confidenziale Lombardia, ItaliaPubblicato il 01/03/2023 · Regulatory affairs · Azienda chimico farmaceutica · Il nostro cliente · Azienda chimico farmaceutica situata in zona Como · Ruolo · La risorsa, rispondendo al manager di dovra' occupare di: · stesura e aggiornamento dei Drug Master Files e della prepara ...
-
Specialista Npl Legal Affairs
3 giorni fa
Banca Ifis S.p.A. Milano, ItaliaRicerchiamo per la Direzione Generale del Gruppo uno Specialista NPL Legal Affairs. · Ricoprendo tale ruolo potrai entrare a far parte di un team composto da sei professionisti e ti occuperai, coadiuvandoti con il Responsabile dell'Unità Organizzativa NPL Legal Affairs, di fornir ...
Regulatory Affairs Manager - Milan, Italia - PharmaLex
Descrizione
Your Job
Your Profile
We offer