Erasmo Addeo Email & Phone Number | As a seasoned regulatory affairs professional with a wealth of experience spanning diverse pharmaceutical landscapes, I bring a proven track record of driving successful regulatory strategies and ensuring compliance in highly regulated markets. In my current role as a Senior Manager, Regulatory Liaison Europe at Organon, I have been instrumental in leading the timely preparation of regulatory strategies and submissions for Marketing Authorization Applications (MAAs). My commitment to maintaining high-quality labelling, managing artwork effectively, and staying abreast of EU regulations reflects my dedication to excellence in regulatory affairs. Previously, as a Global Regulatory Affairs Manager at Angelini, I played a pivotal role in coordinating lifecycle maintenance procedures and navigating regulatory complexities for new Marketing Authorizations, Variations, Renewals, and line extensions. My ability to apply regulatory knowledge in a dynamic environment has significantly contributed to product development and market access. During my tenure as a Combination Product CMC Regulatory Manager at Novartis, I took on the responsibility of serving as the regulatory device expert for the development of combination products and medical devices. This role involved not only ensuring successful and timely registrations in highly regulated markets but also supporting the implementation of the Medical Device Regulation (MDR) across EU Novartis sites. My journey includes significant contributions as a CMC Regulatory Affairs Associate at Eli Lilly and Company, where I excelled in preparing and managing CMC documentation for biotechnological products, handling regulatory impact changes, and providing crucial support during on-site inspections. Complementing my practical experience is a robust educational foundation, including a Second Level University Master’s in Regulatory Affairs and Market Access. Holding licenses as a pharmacist and chemist, coupled with certifications such as Iso 9001:2015 Internal Auditor, underscores my commitment to professional development. My key achievements reflect my capability to work under tight deadlines, effectively manage diverse projects, and foster a collaborative team environment. I am proactive, determined, and consistently seek innovative approaches to enhance processes. As a regulatory affairs professional, I am poised to bring my wealth of expertise to a dynamic team, contributing to the strategic success and regulatory excellence of your organization.

Erasmo Addeo

As a seasoned regulatory affairs professional with a wealth of experience spanning diverse pharmaceu...
Novartis, Biochemiestraße 10, Austria

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Erasmo Addeo’s Email erasmo.addeo@novartis.com

Erasmo Addeo’s Phone Numbers +1 212-830-****

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Erasmo Addeo’s Location Novartis, Biochemiestraße 10, Austria

Erasmo Addeo’s Current Industry Organon

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Work Experience

Organon

Senior Regulatory Liason Europe

2021-07-01 00:00:00 - Present

Angelini Pharma

Global Regulatory Affairs

2019-08-01 00:00:00 - 2021-07-01 00:00:00

Novartis

Combination Products Regulatory Manager

2017-07-01 00:00:00 - 2019-08-01 00:00:00

Merck

Regulatory & CMC compliance Senior Specialist

2016-09-01 00:00:00 - 2017-07-01 00:00:00

Eli Lilly

CMC Regulatory Affairs Specialist

2013-11-01 00:00:00 - 2016-09-01 00:00:00

Dip Di Biochimica E Biofisica Sunf Cedrangolo

Researcher

2012-07-01 00:00:00 - 2013-12-01 00:00:00

Farmacia Pecoraro Dott Ssa Vittoria Palma Campania 80036

Abilitation Trainee to pharmacist profession

2011-11-01 00:00:00 - 2012-05-01 00:00:00

Skills

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Languages

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FAQ About Erasmo Addeo

Erasmo Addeo is located at
Novartis, Biochemiestraße 10, Austria

Erasmo Addeo is a As a seasoned regulatory affairs professional with a wealth of experience spanning diverse pharmaceutical landscapes, I bring a proven track record of driving successful regulatory strategies and ensuring compliance in highly regulated markets. In my current role as a Senior Manager, Regulatory Liaison Europe at Organon, I have been instrumental in leading the timely preparation of regulatory strategies and submissions for Marketing Authorization Applications (MAAs). My commitment to maintaining high-quality labelling, managing artwork effectively, and staying abreast of EU regulations reflects my dedication to excellence in regulatory affairs. Previously, as a Global Regulatory Affairs Manager at Angelini, I played a pivotal role in coordinating lifecycle maintenance procedures and navigating regulatory complexities for new Marketing Authorizations, Variations, Renewals, and line extensions. My ability to apply regulatory knowledge in a dynamic environment has significantly contributed to product development and market access. During my tenure as a Combination Product CMC Regulatory Manager at Novartis, I took on the responsibility of serving as the regulatory device expert for the development of combination products and medical devices. This role involved not only ensuring successful and timely registrations in highly regulated markets but also supporting the implementation of the Medical Device Regulation (MDR) across EU Novartis sites. My journey includes significant contributions as a CMC Regulatory Affairs Associate at Eli Lilly and Company, where I excelled in preparing and managing CMC documentation for biotechnological products, handling regulatory impact changes, and providing crucial support during on-site inspections. Complementing my practical experience is a robust educational foundation, including a Second Level University Master’s in Regulatory Affairs and Market Access. Holding licenses as a pharmacist and chemist, coupled with certifications such as Iso 9001:2015 Internal Auditor, underscores my commitment to professional development. My key achievements reflect my capability to work under tight deadlines, effectively manage diverse projects, and foster a collaborative team environment. I am proactive, determined, and consistently seek innovative approaches to enhance processes. As a regulatory affairs professional, I am poised to bring my wealth of expertise to a dynamic team, contributing to the strategic success and regulatory excellence of your organization.

Erasmo Addeo currently works in the Organon |

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Erasmo Addeo has prior
experience in the following industries:
Angelini Pharma | Novartis | Merck | Eli Lilly | Dip Di Biochimica E Biofisica Sunf Cedrangolo | Farmacia Pecoraro Dott Ssa Vittoria Palma Campania 80036

Erasmo Addeo has the following professional experience:
Organon | Angelini Pharma | Novartis | Merck | Eli Lilly | Dip Di Biochimica E Biofisica Sunf Cedrangolo | Farmacia Pecoraro Dott Ssa Vittoria Palma Campania 80036