Note: The job is a remote job and is open to candidates in USA. Pierre Fabre Laboratories is a global pharmaceutical company seeking a Vice President of Regulatory Affairs and Pharmacovigilance. This role is responsible for overseeing all regulatory affairs and vigilance activities in the US, ensuring compliance with regulations, and managing a team of regulatory professionals.

Responsibilities

• 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)
• Provide regulatory and PV leadership and oversight to a team of six professionals (remote and NJ based) and oversee Regulatory strategy, CMC, Project Management Labeling and promotional activities.
• Ensuring cross-functional effectiveness and optimal networking at the local and corporate levels,
• Ensure appropriate definition, coordination and follow-up of the local RA budget, in close partnership with the corporate,
• Work with e Quality, in the development and implementation of RA policies and procedures consistent with corporate policies and US regulatory requirements
• Ensure that all the key RA activities are performed and achieved according to corporate guidelines and timelines,
• Ensure compliance in all operations & creation of RA SOPs as required.
• Ensure regular reporting of activity through pre-defined local and global metrics.,
• Manage any cross-functional activity related to RA and GxP risk management,
• Business continuity
• Ensures continuity of regulatory, vigilances activities at the local level, including the set-up of a system to cover out of business hours.
• Monitor, communicate and educate the organization on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
• Lead regulatory submissions to FDA. Manages regulatory submissions and related supplements/amendments to the different FDA Divisions in collaboration with Corporate Regulatory Affairs
• Contribute to the authoring and review of regulatory submissions e.g. safety reports, promotional materials, and other relevant documents applicable to Pierre Fabre medicinal products marketed in the US, or under submission.
• Interact directly with FDA and maintain excellent relationship with regulatory personnel.
• Contribute to planning Agency interactions, and lead interactions with FDA (INDs, NDA/MAAs, DSURs, PIND/EOP2 meetings, etc.) in collaboration with the Corporate Regulatory Affairs teams, when relevant

Skills

• Expertise in pharmacovigilance is essential for supervising Local Safety Officers.
• Expert interpretation of requirements for developing and licensing medicinal products in the U.S. market.
• 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