Regulatory affairs - Global Product Lead

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Regulatory affairs - Global Product Lead, como

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Client:

Pharma Point

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

283150358841969868833712

Job Views:

2

Posted:

26.05.2025

Expiry Date:

10.07.2025

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Job Description:

Our client is a multinational pharmaceutical company with a portfolio that includes both innovative and established products.

For the Italian affiliate, we are currently looking for:

Regulatory affairs - Global Product Lead - New Products

This role will spend about 25% of its time being a local Regulatory affiliate representative, serving as the primary contact for the Italian team and overseeing local activities. It will also support the existing product portfolio, working closely with the LCM team, in-country regulatory partners, and Local Health Authorities.

Key responsibilities include:

1. Supporting and guiding the Business Development & Licensing Team in evaluating new projects primarily for EU, UK, and Canada.
2. Preparing global regulatory submission strategies, conducting dossier due diligence, and identifying timelines for new projects reviewed and approved by senior management.
3. Timely preparation and submission of regulatory applications for new pipeline products, including in-licensing, product developments, and registering existing products into new markets.
4. Reviewing and preparing CMC dossier sections.
5. Communicating directly with regulatory authorities to facilitate dialogue on new product submissions and other issues, including pre-submission steps and regulatory procedures (Centralised or DCP).
6. Responding promptly and accurately to regulatory queries related to new products and activities, including RAMA searches.
7. Managing relationships with new partners and their regulatory departments to ensure timely feedback.
8. Reporting on regulatory progress and issues at project meetings and to senior management.
9. Escalating risks or issues to remove barriers or inform delays impacting approval timelines.
10. Proposing improvements or alternative approaches to enhance project outcomes.

Supporting the Italian affiliate:

1. Acting as a liaison between Global Regulatory Affairs and the Italian affiliate, overseeing the Italian product portfolio and being the first contact for clarifications.
2. Coordinating across global regulatory functions, considering country priorities, and facilitating implementation of changes locally.
3. Managing relationships with local regulatory partners, providing strategic support, interacting with local Health Authorities, and overseeing local activities like database updates and stock notifications.

Requirements:

• 7+ years of regulatory experience in pharmaceutical product submissions.
• Experience with EU regulatory authorities, including scientific advice and pre-submission meetings.
• International regulatory experience.
• Expertise in preparing Common Technical Dossiers, including CMC sections.
• Experience with national and European MAA submissions (DCP, Centralized procedure).
• Excellent command of spoken and written English.