Regulatory Affairs Head

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Regulatory Affairs Head, Italia/Lombardia

Location:

Other

EU work permit required:

Yes

Job Reference:

526131333

Job Views:

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.

• 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.

• Proven experience in Regulatory Affairs within an API manufacturing environment.
• Strong team management and leadership skills.
• Fluent English proficiency, both written and spoken.