Vice President, Regulatory Affairs and Pharmacovigilance

Your Mission

Reporting to the Chief Executive Officer of Pierre Fabre Pharmaceuticals (PFP), the Vice President of Regulatory Affairs (RA) and Pharmacovigilance (PV) is a vital member of PFP's leadership team and of the Global Regulatory Affairs organization. This role involves overseeing all regulatory affairs and vigilance activities in the US for the company's portfolio. The Vice President ensures that Pierre Fabre Pharmaceuticals Inc. has the necessary resources and processes to comply with U.S. regulations and the global Regulatory and Pharmacovigilance processes. Responsibilities include maintaining compliance with corporate guidelines and standard operating procedures (SOPs), as well as managing risk at all levels of the subsidiary. Expertise in pharmacovigilance is essential for supervising Local Safety Officers, in collaboration with Corporate Vigilance management. Additionally, this position requires expert interpretation of requirements for developing and licensing medicinal products in the U.S. market. The Vice President works with the Medical Care Global Regulatory Affairs organization, particularly with the Regulatory Development, Lifecycle Management, and Regulatory Operations teams and the Global Pharmacovigilance organization.

Who You Are?

Essential Functions :

• Guide and direct the regulatory team to ensure appropriate regulatory strategy requirements are met for early development, late development and commercial products.
• Support the U.S. and corporate organizations in regulatory due diligence activities.
• Responsible for all regulatory and Pharmacovigilance activities in the US.
• Responsible for Regulatory approval of promotional and non-promotional communication and training in accordance with US and international applicable regulations.
• Responsible for Regulatory CMC, and close working relationship with Technical Operations and Quality.
• Responsible for the Regulatory Labeling life cycle activities.
• Responsible for the Regulatory Project Management activities partnering with the Global Regulatory Affairs, R&D and Technical Operations organizations and the U.S. teams.
• Responsible for the Regulatory Operations activities including the U.S. submission preparation and publishing.
• Ensure enterprise alignment in the development and maintenance of marketed products in US.
• Manage US regulatory vendors and budget.
• Represent interest in local trade associations and share information with internal stakeholders.
• Ensure that the appropriate resources and processes are set-up and in place in US to support Pierre Fabre Pharmaceuticals Inc. product life cycle management.
• Responsible for Regulatory compliance oversight and management of the Regulatory Information System database (RIM).

PV Team Management :

Anticipated Base Pay Range - $275,000 - $315,000

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.