Regulatory Submission Manager
Current
Mar 2023 - Present
Who is Anna Conte? Overview
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Quick answer
Anna Conte is listed as Country Start Up Specialist at Fortrea, based in Italy. AeroLeads shows a work email signal at labcorp.com and a matched LinkedIn profile for Anna Conte.
Anna Conte previously worked as Regulatory Submission Manager at Fortrea and Senior Global Regulatory Affairs at Pra Health Sciences. Anna Conte holds Laurea, Chimica Farmaceutica from Alma Mater Studiorum – Università Di Bologna.
Company email context
Email format at Fortrea
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{first}.{last}@labcorp.com
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Profile bio
About Anna Conte
More thank 20 years experience in the clinical trials II-IV Phases, as CRA; LCRA; PM and Clinical Operation Specialist, specialised in the Start Up activities and finally in the Global Regulatory Affairs activities. Actually responsible for the management of a team of regulatory professionals for ensuring all timely submissions of appropriate documentation to RA globally. Responsible for providing regulatory consultancy advice to client companies and to internal project team.
Listed skills include Clinical Trials, Clinical Research, Pharmacovigilance, Oncology, and 19 others.
Current workplace
Anna Conte's current company
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9 roles · 34 years
Anna Conte work experience
A career timeline built from the work history available for this profile.
Senior Global Regulatory Affairs
Jan 2019 - Mar 2023
Regulatory Affairs Specialist
Comply with SOPs, ICH GCP and national regualtions; review and make recommendations on all relevanat documentation e.g. labels, patient information sheets, diary cards to ensure compliance with ICH GCP & Country specific requirements; coordinate & manage regulatory & ethics committe submissions and mantain approvals.
Sep 2012 - Dec 2018
Country Start Up Specialist
Supervises clinical operation staff dedicated to country start-up activities; Participate in the design and development of Patient Informed Consent Templates in accordance with applicable regulations/requirements and of other protocol specific documents as required; Provides Oversight of Ministry of Health submnission directly ; liases with Regulatory Affairs to ensure Ministry of Health submission is performed ; Participates in the Investigational Product Release Process; provides Oversight of local/Central Ethics Committe submission. Performs all aspects of Clinical Start-Up activities at the Country level to achieve successful activation of sites in accordance with ICH GCP, FDA regualtions, applicable regulations, requirements and SOP.
Jul 2010 - Aug 2012
Ihcra
Pra Internatinal
Performs Investigator Evaluation and Recruitment; Performs Essential Document Collection, Review, Maintenance and Close Out activities; Ensures sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines; Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals; Liaises with project team members regarding study sites issues; Provides quality review of the informed consent template; Supports Clinical Team Lead to resolve internal and external clinical issues for client research projects managed by PRA; Creates and maintains clinical project documents, including Clinical Management Plans, Monitoring Guidelines, Site Operations Manuals and Monitoring Visit Letter Templates ;Supports Clinical Team Lead in management of clinical budget and evaluation of study processes
Apr 2007 - Jun 2010
Pharmacist
Private Pharmacy
2003 - 2006
~3 yrs
Cra And Projetc Manager
Cro
1995 - 2003
~8 yrs
Cra
Hyperphar
1994 - 1996
~2 yrs
Expert In Chemical Patent
1993 - 1994
~1 yr
2 education records
Anna Conte education
Laurea, Chimica Farmaceutica
Education record
Liceo Scientifico
FAQ
Frequently asked questions about Anna Conte
Quick answers generated from the profile data available on this page.
What company does Anna Conte work for?
Anna Conte works for Fortrea.
What is Anna Conte's role at Fortrea?
Anna Conte is listed as Country Start Up Specialist at Fortrea.
What is Anna Conte's email address?
AeroLeads has found 1 work email signal at @labcorp.com for Anna Conte at Fortrea.
Where is Anna Conte based?
Anna Conte is based in Italy while working with Fortrea.
What companies has Anna Conte worked for?
Anna Conte has worked for Fortrea, Pra Health Sciences, Pra International, Pra Internatinal, and Private Pharmacy.
How can I contact Anna Conte?
You can use AeroLeads to view verified contact signals for Anna Conte at Fortrea, including work email, phone, and LinkedIn data when available.
What schools did Anna Conte attend?
Anna Conte holds Laurea, Chimica Farmaceutica from Alma Mater Studiorum – Università Di Bologna.
What skills is Anna Conte known for?
Anna Conte is listed with skills including Clinical Trials, Clinical Research, Pharmacovigilance, Oncology, Pharmaceutical Industry, Ctms, Clinical Monitoring, and Gcp.
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