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Regulatory Affairs Specialist

2 mesi fa

Milano, Lombardia, Italia Page Personnel A tempo pieno
Regulatory Affairs Job Description

**Key Responsibilities:**

* Manage and prepare regulatory dossiers for submissions of human drug substances in the US, EU, and extra-EU markets.
* Prepare and manage dossiers in response to deficiency letters from authorities and in accordance with applicable changes.
* Oversee the preparation and management of renewals and annual reports.
* Evaluate changes and ensure compliance with regulatory requirements.
* Support the management of customer variations and regulatory strategy for Investigational Medicinal Products (IMPD).
* Collaborate with the team to evaluate and edit SOPs.

**Requirements:**

* A degree in a scientific field
* Regulatory experience in a pharmaceutical company

**About the Opportunity:**

This is a critical role for our client, requiring a skilled regulatory affairs professional to drive compliance and strategy.