Regulatory Affairs Head Milano

Regulatory Affairs Head
Milano
Lombardia, Milano

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5 Posted:

14. 02. 2025 Expiry Date:

31. 03. 2025 Job Description:

We are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a

Regulatory Affairs Head.

Key Responsibilities:

Lead and manage the Regulatory Affairs team, ensuring proper training and professional development.

Supervise the preparation, updates, and submission of European and international regulatory dossiers.

Define and periodically review the company's quality policy and its implementation.

Collaborate with Quality Assurance to assess changes with potential regulatory impact on the quality of APIs.

Assist clients in preparing documentation to meet legal and regulatory requirements.

Partner with the R&D department to evaluate regulatory aspects of product development data.

Oversee responses to deficiency letters from regulatory authorities.

Review CMC documentation for APIs, including CTD, Site Master Files, and responses to authority inquiries.

Support DMF preparation and submission in international markets according to national and international regulations.

Requirements:

Proven experience in Regulatory Affairs within an API manufacturing environment.

Strong team management and leadership skills.

Fluent English proficiency, both written and spoken.

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