International Regulatory Affairs Manager

1 settimana fa

Pisa, Italia Regulatory Pharma Net A tempo pieno

We provide 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 professional to join our growing International Team.
You will play a key part in managing regulatory requirements to support product development, registration, and lifecycle management across multiple markets. Your knowledge will ensure compliance with local and international regulations, helping to successfully launch and maintain innovative products globally.
What will you be responsible for?
Preparing regulatory documentation for development programs (IMPDs/INDs, IBs, CTAs, Scientific Advice, Orphan Drug Designation).
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.
Do you meet these essential requirements?
Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
At least 8 years of experience.
Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
Do you bring the following interpersonal skills?
Strong attention to detail and a structured working approach.
Proactive mindset with solid problem-solving abilities.
Excellent communication skills.
Flexibility and adaptability in a dynamic environment.
**Work place**:
Pisa (hybrid position).

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