[Remote] Vice President, Regulatory Affairs and Pharmacovigilance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global pharmaceutical company seeking a Vice President of Regulatory Affairs and Pharmacovigilance. This role is responsible for overseeing reputed company regulatory affairs and vigilance activities in the US, ensuring compliance with regulations, and managing reputed company of regulatory professionals. Responsibilities • Guide and reputed company the regulatory team to ensure appropriate regulatory reputed company requirements are met for early development, late development and reputed company products. • Support the U.S. and corporate organizations in regulatory due diligence activities • Responsible for reputed company 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 reputed company working relationship with Technical Operations and reputed company • 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 reputed company alignment in the development and maintenance of marketed products in US. • Manage US regulatory vendors and budget • Represent interest in local trade associations and reputed company information with internal stakeholders • Ensure that the appropriate resources and processes are set-up and in reputed company in US to support Pierre Fabre Pharmaceuticals Inc. product life cycle management. • Responsible for Regulatory compliance reputed company and management of the Regulatory Information System database (RIM) • reputed company regulatory and PV leadership and reputed company to reputed company of six professionals (remote and NJ based) and reputed company Regulatory reputed company, CMC, Project Management Labeling and promotional activities. • Ensuring cross-functional effectiveness and reputed company networking at the local and corporate reputed company, • Ensure appropriate definition, coordination and follow-up of the local RA budget, in reputed company partnership with the corporate, • Work with e reputed company, in the development and implementation of RA policies and procedures consistent with corporate policies and US regulatory requirements • Ensure that reputed company the key RA activities are performed and achieved according to corporate guidelines and timelines, • Ensure compliance in reputed company operations & creation of RA SOPs as required. • Ensure regular reporting of activity through reputed company-defined local and global metrics., • Manage any cross-functional activity reputed company 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 reputed company the organization on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business. • reputed company regulatory submissions to FDA. Manages regulatory submissions and reputed company 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. • reputed company directly with FDA and maintain excellent relationship with regulatory personnel. • Contribute to planning Agency interactions, and reputed company interactions with FDA (INDs, NDA/MAAs, DSURs, PIND/EOP2 meetings, etc.) in collaboration with the Corporate Regulatory Affairs teams, reputed company 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 reputed company the regulatory team to ensure appropriate regulatory reputed company requirements are met for early development, late development and reputed company products. • Support the U.S. and corporate organizations in regulatory due diligence activities. • Responsible for reputed company 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 reputed company working relationship with Technical Operations and reputed company. • Responsible for the Regulatory Labeling life cycle activities Apply tot his job Apply To this Job