-
Manager, Global Regulatory Affairs
3 settimane fa
GSK Siena, Italia**Site Name**: Italy - Siena · **Posted Date**: Jun 6 2023 · **Manager, Global Regulatory Affairs** · **(maternity cover)** · We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learni ...
-
regulatory affairs manager
1 settimana fa
Philogen Siena, ItaliaPhilogen would like to hire a Regulatory Affairs Manager who will report to the Management and will provide support in formulating and implementing regulatory strategies for the development of Company Products in close collaboration with other functions in the Clinical Department ...
-
Director, Global Medical Affairs Lead
3 settimane fa
GSK Siena, Italia**Site Name**: Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Siena, UK - London - Brentford · **Posted Date**: May · **Director/Senior Director Global Medical Affairs Lead - Scientific Affairs & Public Health, Global Health Access**: · Are you motivated by GSK's Global Health ...
-
Commercial Operations Italy; Key Account Manager
1 settimana fa
Seqirus A CSL Company Siena, ItaliaThe Key Account Manager position sits as part of the Commercial Operations Team Italy; this role will be working within the Triveneto region. · Responsibilities include: · - Develops and maintains trust relationships with key regional accounts and KOLs to increase product awarene ...
-
Manager, Cmc Vx Mature Products
3 settimane fa
GSK Siena, Italia**Site Name**: Belgium-Wavre, GSK Asia House, GSK House, Italy - Siena · **Posted Date**: Apr · You will be responsible for the CMC regulatory activities of multiple projects. · **Key responsibilities**: · - You drive the CMC strategy, coordinates the timely preparation and auth ...
-
Manager, Gra Cmc Vx Mature Product
2 settimane fa
GSK Siena, Italia**Site Name**: Italy - Siena, Belgium-Wavre, Poznan Business Garden · **Posted Date**: Aug 8 2023 · **Manager, GRA CMC Vx Mature Product**: · **Job Purpose**: · Responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of G ...
-
Director Vaccines Development Cmc
6 giorni fa
GSK Siena, Italia**Site Name**: Belgium-Wavre, Italy - Siena, UK - London - Brentford, USA - Massachusetts - Waltham · **Posted Date**: May · **Job purpose**: · As the Director Vaccines Development CMC you, · - Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy a ...
-
Manager, Cmc Vx Mature Products
4 giorni fa
GSK Siena, Italia**Site Name**: Belgium-Wavre, GSK House, Italy - Siena · **Posted Date**: Apr 4 2023 · You will be responsible for the CMC regulatory activities of multiple projects. · **Key responsibilities**: · - You drive the CMC strategy, coordinates the timely preparation and authors, as ne ...
-
Gvgh Ra Expert
4 giorni fa
GSK Siena, Italia**Site Name**: Italy - Siena · **Posted Date**: Mar 8 2023 · **GVGH RA Expert** · **(Fixed Term)** · **In this role you will** · Support early development (up to clinical Phase 2) of vaccines for global health from regulatory perspective through: · - Support development and maint ...
-
Clinical Operations Asset Lead
3 giorni fa
GSK Siena, Italia**Site Name**: Italy - Siena, Belgium-Wavre, Bengaluru Luxor North Tower, Poznan Business Garden Pastelowa, UK - London - Brentford · **Posted Date**: May · **Clinical Operations Asset Lead - Vaccines** · **The role**: · The Clinical Operations Asset Lead Role is a highly visibl ...
-
Medical Scientific Liaison
1 settimana fa
Grifols Italia SpA Siena, ItaliaWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...
-
Head of Bacterial Projects
1 ora fa
GSK Siena, Italia**Site Name**: Italy - Siena · **Posted Date**: Jul 3 2023 · **Head of Bacterial Projects**: · Reporting to the VP, Global Health R&D Vaccines Head and GVGH Institute Director, the Head of Bacterial Projects will provide strong leadership for the discovery and development portfol ...
-
Seqirus Monteriggioni, ItaliaThis is a Maternity Leave position for a Marketing and Sales Lead Coordinator based in Siena · Part of the Commercial operations Italy team, this role coordinates a variety of critical business functions in support of the Marketing & Sales team, such as promotional and communicat ...
-
Clinical Trial Assistant
3 settimane fa
Pharma D&S Scandicci, ItaliaPharma D&S ricerca un/una Clinical Trial Assistant con almeno 1 anno di esperienza maturata come CTA o Study Coordinator, in ambito Ricerca Clinica. · La risorsa selezionata si occuperà di: · - assistere il Project Manager nelle attività di impostazione dello studio; · - assister ...
-
Talent Acquisition Specialist
2 settimane fa
Pharma D&S Scandicci, ItaliaPharma D&S ricerca un Talent Acquisition Specialist. · La risorsa selezionata si occuperà di: · - Stesura e pubblicazione dell'annuncio sui principali canali di reclutamento · - Preparazione short list da presentare all'HR Manager o Operation Manager · I requisiti: · - Laurea in ...
-
Gucci Internship Opportunities in Legal Department
2 settimane fa
Groupe Kering Scandicci, Italia StageSHIPSummary · Are you ready to start your GUCCI Journey? · Join the Legal Teams in our Headquarters based in Florence · At Gucci we are all people moved by passion and thought but we're also those who never forget to dream and to look towards the future. · That is why we are always l ...
-
Clinical Trial Assistant
6 giorni fa
Pharma D&S Scandicci, ItaliaPharma D&S ricerca un/una Clinical Trial Assistant con almeno 1 anno di esperienza maturata come CTA o Study Coordinator, in ambito Ricerca Clinica. · La risorsa selezionata si occuperà di: · - assistere il Project Manager nelle attività di impostazione dello studio; · - assister ...
-
Business Development Lead
2 settimane fa
1849 GlaxoSmithKline Biologicals S.A. Siena, Italia A tempo pienoBusiness Development Lead– Global Health · Job Purpose · This role is critical to support senior management as well as Gov Affairs and Global functions by providing expert BD support and leadership on a range of activities covering the strategic design of Global Health (GH) pa ...
-
Business Development Lead
1 settimana fa
Tn Italy Siena, Italiacol-wideJob Description:Business Development Lead– Global HealthJob PurposeThis role is critical to support senior management as well as Gov Affairs and Global functions by providing expert BD support and leadership on a range of activities covering the strategic design of Global ...
-
Medical Scientific Liaison
1 settimana fa
Grifols Siena, Italia Regular A tempo pienoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...
Regulatory Affairs Manager - Siena, Italia - Philogen
Descrizione
Philogen would like to hire a Regulatory Affairs Manager who will report to the Management and will provide support in formulating and implementing regulatory strategies for the development of Company Products in close collaboration with other functions in the Clinical Department.
In particular, the selected candidate will carry out the following tasks: Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory bodies:Develop content, timelines and contingencies for submissions in collaboration with internal and external contributorsEnsure that submissions are of high quality, meet all regulatory requirements and comply with corporate goals and directivesReviewing draft registration files and submitting new and amended registration dossiers to obtain and maintain registrationGathering, evaluating, and organizing information necessary for regulatory agencies and other third parties;Coordinate and participate in the preparation of different types of regulatory submissions (e.g.dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental productsProvide regulatory feedback to project teams and senior managementParticipate in contacting competent authorities for respective projects/products and interact with internal departmentsPerforming the registration, update and posting of results of Philogen studies in mandatory clinical trials and publication databases;Management of procedures related to Marketing Authorisation Applications for EMA and FDA;Managing the update of the Trial Master File and archiving of the documentation regarding the Competent Authorities and Ethics Committees of all Philogen studies in collaboration with the CTA;Prepare and revise controlled documents including clinical Forms, Templates and Standard Operating Procedure (SOPs) referred to the Regulatory Affairs;Training clinical staff in regulatory policies or procedures;Keeping up-to-date with changes in regulatory legislation and guidelines and evaluating applicable laws and regulations to determine impact on department activities;Preferably experience of but definitely an awareness of the key electronic submission toolsRequirements: University degree in science (preferred)At least 5 years' experience in regulatory affairsExperience in Regulatory Life Cycle Management and eCTD is an advantage, although not requiredA thorough understanding of ICH GCP and regulatory requirements worldwide (particularly FDA and EMA)Excellent written and oral communication skills.
An excellent level of English, both written and spoken.We offer:
A contract and salary proportional to the experience of the successful candidate
Job location:
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address
, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
