REGULATORY AFFAIRS - GLOBAL PRODUCT LEAD

Pharma Point Srl; Milano; In loco; EUR 60.000 - 100.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Regulatory Affairs - Global Product Lead to oversee local activities and support new product submissions. This role requires a seasoned professional with over 7 years of regulatory experience, particularly in engaging with EU authorities and preparing Common Technical Dossiers. You'll be pivotal in managing relationships with local regulatory partners while ensuring compliance and facilitating communication across global functions. Join a dynamic team where your expertise will directly impact the success of innovative pharmaceutical products in the market.

Competenze

• 7+ years of regulatory experience in pharmaceutical submissions.
• Significant experience preparing Common Technical Dossiers.

Mansioni

• Support and guide the Business Development & Licensing Team.
• Act as liaison between Global Regulatory Affairs and the Italian affiliate.

Conoscenze

Regulatory Experience

Communication with Regulatory Authorities

Dossier Preparation

Project Management

Strategic Support

Formazione

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Descrizione del lavoro

REGULATORY AFFAIRS - GLOBAL PRODUCT LEAD

Business unit: Regolatorio

Sedi: Italia / Lombardia / Milano

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

We are currently looking for a:

Regulatory Affairs - Global Product Lead - New Products

This role will dedicate approximately 25% of its time to representing the local Regulatory affiliate, 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:

New Submission / In-Licensing Support:

• Support and guide the Business Development & Licensing Team in evaluating new projects, primarily for the EU, UK, and Canada.
• Develop regulatory submission strategies globally, conduct dossier due diligence, and establish timelines for new projects reviewed and approved by senior management.
• Prepare and submit regulatory applications for new pipeline products, including in-licensing, product development, and registration of existing products into new markets.
• Review and prepare CMC dossier sections.
• Maintain direct communication with regulatory authorities to facilitate productive dialogue on submissions and other relevant issues, including pre-submission steps and regulatory procedures (Centralized or DCP).
• Respond promptly and accurately to regulatory queries related to the New Products group activities, including RAMA searches.
• Manage relationships with new partners and their regulatory departments to ensure timely feedback on queries.
• Report on regulatory progress and issues at project team and senior management meetings.
• Escalate risks or issues to remove barriers or inform about delays that could impact approval timelines.
• Propose improvements or alternative approaches to enhance project deliverables.

Affiliate / In-country Local Italian Support:

• Act as liaison between Global Regulatory Affairs and the Italian affiliate, overseeing the portfolio and serving as the first contact for clarifications.
• Coordinate across global regulatory functions, considering country priorities and facilitating local implementation of changes.
• Manage relationships with local regulatory partners, provide strategic support, interact with local Health Authorities, and oversee local activities like database updates and out-of-stock notifications.

Requirements:

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