Francesco Arone
Regulatory Affairs Manager
Milano,Lombardy
Summary
Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.
Overview
20
20
years of professional experience
6
6
years of post-secondary education
Work History
Global RA Manager
VIATRIS
01.2020 - Current
- Manage team dealing with RA activities of Food Supplements (FS) and Cosmetics (CS) at Global level (both EU and extra-EU countries, such as CIS, Asia, Latin America, Middle East).
- As Global RA Manager, accountable to follow EU legislative updates related to FS and CS and to disseminate them to all involved functions (R&D, Quality, Safety, Manufacturing), as well as to manage assessment of impact of such updates to product portfolio by team and by the manufacturing plant. On average 60 communications of legislative updates disseminated each year, by mail and regular meetings.
- Manage activities related to new registrations of FS and CS world-wide and maintenance of existing registrations world-wide ensuring that technical and administrative documentation is prepared by team members in timely manner. About 30 new notifications/registration and 100 variations obtained per year.
- With particular reference to launch of new products, assess directly or oversee evaluation of packaging texts from RA perspective.
- Oversee preparation of Product Information Files of CS and Technical Dossiers of FS, in accordance to applicable regulations, as well as updating of Company databases. About 80 PIF and FS dossier updated each year.
- In addition, I take part to cross-functional meetings with marketing, medical, R&D teams related to the geo-expansion of existing products or launch of new products
- Deal with assessment of regulatory acceptability of new products in specific markets of interest, directly or supervising work of team
- Prepare also plan of new registrations and variations of existing registrations in extra-EU countries (EU countries are usually managed based on product order).
Regulatory Affairs Coordinator
MYLAN
01.2018 - 02.2020
- Follow registration and maintenance of authorizations of food supplements and cosmetics, under supervision of Head of QA&RA and in collaboration with QA/R&D for new authorizations, also preparing, or having the necessary technical / regulatory documentation prepared
- Support R&D activities and evaluates regulatory classification of new and existing products
- Act as coordinator of the RA Team for Cosmetics and Supplements in support of the Head of QA&RA
- Guarantee Business Continuity by complying with RA requirements in accordance with current legislation for all Cosmetics and Supplements under responsibility of GPPS
- Collaborate with various company functions for maintenance and updating of databases and regulatory portals (e.g. CPNP)
- Guarantee dissemination of legislative updates relating to product classes within its competence
- Participate in R&D activities by evaluating the regulatory compliance in EU and non-EU countries of new products under development, in terms of composition and labeling prototypes.
Regulatory Affairs Specialist
MEDA PHARMA
01.2014 - 08.2018
- Notification / registration of food supplements and cosmetics in EU, Asia, Middle East and Latin America
- Evaluation of product compositions against applicable regulations (Directive 2002/46/EC, Regulation 1333/2004, Regulation 1334/2008, national lists, Regulation 1223/2009, CosIng database)
- Check of packaging texts for compliance to regulations (Regulation 1169/2011, Regulation 655/2013)
- Opening artwork change control request, check and final approval
- Taking part in writing Technical dossier of Food Supplements, in cooperation with the manufacturing plant.
Regulatory Affairs Officer, international Operations
Rottapharm S.p.A.
01.2006 - 09.2014
- Preparation of dossier for new registration applications, renewals, quality and SPC variations of Medicinal Products in EU and extra-EU countries (Russia, Asia, Middle East, Latin America)
- Type I and Type II variations, line extension, switch to OTC classifications
- Review of SPC, PIL and label texts in accordance to QRD templates
- Support local affiliates in notifications and registrations of notifications, registrations of food supplement in EU and extra-EU countries
- Also registrations of cosmetics and medical devices in extra-EU.
Regulatory Affairs officer, national operations
Rottapharm S.p.A.
05.2005 - 12.2005
- Preparation and Submission of renewal and variation applications to Italian Medicine Agency (AIFA)
- Managing publication on the Official Gazette of variation and registration approvals
- Update of packaging texts
- Check of artworks of new products for launch and existing products after variations.
Stager
Astra Zeneca
06.2004 - 06.2004
- Support preparation of dossier for pricing and reimbursement application, prescription medicinal products within the Economic Affairs department.
Education
Master of Science - Pharmacy
Università Della Calabria
Cosenza, Italy 04.1998 - 01.2004
Skills
Accuracy and efficiency in documentation
undefinedPersonal Information
- Date of Birth: 02/21/1978
- Gender: Male
- Nationality: Italian
Timeline
Global RA Manager
VIATRIS
01.2020 - Current
Regulatory Affairs Coordinator
MYLAN
01.2018 - 02.2020
Regulatory Affairs Specialist
MEDA PHARMA
01.2014 - 08.2018
Regulatory Affairs Officer, international Operations
Rottapharm S.p.A.
01.2006 - 09.2014
Regulatory Affairs officer, national operations
Rottapharm S.p.A.
05.2005 - 12.2005
Stager
Astra Zeneca
06.2004 - 06.2004
Master of Science - Pharmacy
Università Della Calabria
04.1998 - 01.2004
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