Top Biopharma with 'cutting-edge' products; this company is significantly growing - this is a rare Biotech commercial opportunity.

The Associate Director, International Commercial Regulatory Affairs will be responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications for products, and/or development programs. This role works with cross-functional teams and manages regulatory aspects of review and approval of international communications and activities to ensure that the organization's needs are met in compliance with applicable regulatory requirements.

Provides specialized knowledge on EU region regulations and requirements governing product promotion and related communications, including pipeline and disease state communications.

Serves as Regulatory reviewer for assigned product(s) on International Communication Review Committee (CRC), local country CRCs (as assigned), and as Regulatory CoRA representative on programme and other cross-functional teams.

Serves as CRC Chair for assigned product(s) and therapeutic area(s), leading discussions between Regulatory, Legal, Medical, Commercial, and other stakeholders to reach consensus CRC decisions.

In collaboration with Medical, Legal and Commercial, provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications.

As a regulatory reviewer, assesses the regulatory context and provide regulatory interpretations of applicable codes, regulations, and/or guidance or regulatory precedents, including requirements related to submission of materials to Health Authority (HA)

Provides guidance and input for development of products reflective of promotional considerations.

Provides direction and work collaboratively to ensure that changes in product labelling are carried into promotional materials in accordance with company procedures and regulatory requirements.

Collaborates in cross-functional efforts to develop and update procedures and guidelines related to CRC processes.

Monitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of products.

Plans and conducts training sessions as needed with stakeholders.

You will be adept in Strategy & Tactics and have good experience in dealing with Affiliates.

Desirable Central/West London location which is also convenient for those who live West of London in Berkshire. Some Travel may be required in this role.