Your mission

Reporting to the Chief Executive Officer of Pierre Fabre Pharmaceuticals (PFP) theVice President of Regulatory Affairs (RA) and Pharmacovigilance (PV)is a vital member of PFPs leadership team and of the Global Regulatory Affairs organization. This role involves overseeing all regulatory affairs and vigilance activities in the US for the companys 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 pharmacovigilanceis 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.

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)

RV Team Management

• 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.

Regulatory Submission & stakeholder management

• 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

REQUIRED EDUCATION AND EXPERIENCE:

• Advanced degree (PhD PharmD MD MSc) with experience in regulatory affairs and GxP environment and knowledge in Pharmacovigilance
• Seasoned professional with at least 12 years of regulatory affairs experience in the biopharmaceutical industry
• Experience in a leadership role within the regulatory affairs function
• In-depth working knowledge of US regulations and regulatory requirements and operational knowledge of IND/NDA/BLA submissions
• Strong track record of building an excellent relationship with FDA
• Experience on providing strategic advice on integrated regulatory development plans in oncology and rare disease; Experience in gene/cell therapies preferred.
• Experience with development of biomarkers and IVD companion diagnostics devices would be a plus.
• Experience in Safety (especially operational PV) qualification per training and Over 2 (two) years experience in Pharmacovigilance
• Demonstrated success in defining and implementing SOP at a local level are mandatory

• Training or previous successful experience in risk management or equivalent is mandatory

WORK ENVIRONMENT:

• Remote and/or Hybrid (2x days in office)
• Domestic travel up to 30% required with occasional global travel
• If employee is remotely located regular overnight travel to headquarters will be required (Secaucus NJ)

LOCATION: US remote and/or hybrid

Anticipatedbasepayrange-$275000-$315000

Benefits of being a Pierre Fabre Employee

Join Pierre Fabre for competitive benefits including three medical plans dental and vision coverage voluntary benefits a 401(k) plan and more! Our offerings also include a hybrid work policy a generous PTO policy and company holidays paid parental leave discounts on our products learning and development opportunities and access to mental health and wellness programs creating a well-rounded work experience for our employees.

Pierre Fabre

Pierre Fabre has been recognized by Forbes as one of the Worlds Best Employers for the 3rd year running.

to My Nature

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race creed color age national origin ancestry religion gender sexual orientation gender expression and identity disability genetic information veteran status military status application for military service or any other class protected by state or federal law.