Pierre Fabre Laboratories ยท 1 month ago
Vice President, Regulatory Affairs and Pharmacovigilance
United States
Full-time
Remote
Director/Executive
$275K/yr - $315K/yrPierre 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.
BiotechnologyPharmaceuticalTherapeutics
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
Qualification
Required
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 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 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
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
Company
Pierre Fabre Laboratories
Laboratoires Pierre Fabre held by the Pierre Fabre Foundation, is a worldwide company with a unique positioning : the alliance of pharmaceutical and dermocosmetics expertise.
Founded in 1962
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Lisa Morris
President & CEO Pierre Fabre USA
Mathieu CLEMENT
CFO USA
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