Drug Development & Regulatory Affairs Manager

Pisa - Italy

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

RPN provides pharmaceutical and life science companies with the strategic in-market and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.

We are looking for a REGULATORY AFFAIRS & DRUG DEVELOPMENT MANAGER to join ourgrowing team who will play a key part in managing regulatory requirements to support product development registration and lifecycle management across multiple markets.

WHAT WILL YOU DEAL WITH

Preparing regulatory documentation for development programs (IMPDs/INDs IBs CTAs Scientific Advice Orphan Drug Designation).
Supporting marketing authorization applications (CTD Modules) and managing regulatory variations (Module 3 updates).
Conducting risk assessments (elemental impurities environmental risks) and ensuring compliance with applicable guidelines.
Coordinating and preparing responses to regulatory authorities during procedures and interactions.
Identifying risks in submissions and proposing proactive mitigation strategies.
Collaborating with internal teams and regulatory authorities to ensure timely and successful submissions.
Planning and managing EU and non-EU regulatory procedures (MAAs variations renewals).
Supporting regulatory strategy development and providing guidance to clients.
Contributing to project management activities and mentoring junior regulatory staff.

WHAT ARE THE REQUIREMENTS

Masters degree in Pharmaceutical Chemistry and Technology Pharmacy or similar.
At least 8 years of experience in similar roles.
Excellent knowledge of English(written and spoken) essential for frequent contacts with international companies.
Strong project management skills excellent communication abilities and a team oriented mindset with the capacity to coordinate complex projects facilitate stakeholder dialogue and collaborate effectively within multidisciplinary teams.

The selection respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender sexual orientation age ethnicity and religious belief. This announcement is designed to respect diversity and inclusiveness.

RPN provides pharmaceutical and life science companies with the strategic in-market and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.We are looking for a REGULATORY AFFAIRS &...

WHAT WILL YOU DEAL WITH

Preparing regulatory documentation for development programs (IMPDs/INDs IBs CTAs Scientific Advice Orphan Drug Designation).
Supporting marketing authorization applications (CTD Modules) and managing regulatory variations (Module 3 updates).
Conducting risk assessments (elemental impurities environmental risks) and ensuring compliance with applicable guidelines.
Coordinating and preparing responses to regulatory authorities during procedures and interactions.
Identifying risks in submissions and proposing proactive mitigation strategies.
Collaborating with internal teams and regulatory authorities to ensure timely and successful submissions.
Planning and managing EU and non-EU regulatory procedures (MAAs variations renewals).
Supporting regulatory strategy development and providing guidance to clients.
Contributing to project management activities and mentoring junior regulatory staff.

WHAT ARE THE REQUIREMENTS

Masters degree in Pharmaceutical Chemistry and Technology Pharmacy or similar.
At least 8 years of experience in similar roles.
Excellent knowledge of English(written and spoken) essential for frequent contacts with international companies.
Strong project management skills excellent communication abilities and a team oriented mindset with the capacity to coordinate complex projects facilitate stakeholder dialogue and collaborate effectively within multidisciplinary teams.