Senior Manager, Regulatory Operations

Job title:

Senior Manager, Regulatory Operations

Company

Pierre Fabre

Job description

Your missionSenior Manager, Regulatory OperationsAt Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better. We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre’s foundation ownership enhances our ability to focus on creating long-term value for patients.Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.Pierre Fabre Pharmaceuticals is headquartered in Parsippany, NJ alongside Pierre Fabre USA Inc., a Pierre Fabre Laboratories subsidiary focused on dermatology and cosmetics.SUMMARY:Pierre Fabre is a large private French multinational pharmaceutical and cosmetics company building a new US oncology division. We are looking for creative, highly motivated individuals to help prepare for the successful launch of potentially the first allogeneic T-cell immunotherapy approved in the US (“Therapy”). Patients with a history of bone marrow or solid organ transplant can suffer from this rare, often deadly lymphoma, which currently has no approved FDA therapies. Pierre Fabre Pharmaceuticals in the US currently markets HEMANGEOL® (propranolol hydrochloride) oral solution indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.The Senior Manager, Regulatory Operations will lead the Regulatory Operations activities and partner with the Worldwide Regulatory Affairs organization to support the submission and project management activities for the Pierre Fabre Pharmaceutical US (PFP) product portfolio. The Regulatory Operations Manager supervises and executes electronic submission activities that support PFP drug product applications, drug listings, establishment registrations, and safety reports. This role partners with the Worldwide Regulatory Organization for submission scheduling and deliverables and ensuring deadlines are met. This role also serves as a training and knowledge US resource for Regulatory submissions and Veeva RIM system. Propose process improvements and efficiencies. This is an exciting opportunity to be part of an organization that is preparing to launch a new class of advanced therapeutics while making a meaningful impact in the lives of patients with a life-threatening disease.ESSENTIAL FUNCTIONS:

• Support new Veeva Registrations, Submissions, and Submissions Archive RIM system. Manage the daily affiliate operation of the system and serve as the US key user.
• Provide operational oversight, scheduling, and execution of Regulatory eCTD submissions, post-market SAE reporting, and FDA drug listing, establishment registration, and drug distribution reporting. Ensure submissions are compliant with regulations and guidance.
• Provide advice on content and structure of submissions, setup meetings, create timelines, format, and publish files, and manage participants and deadlines.
• Manage content compilation and submission of US FDA annual and aggregate safety reports. Ensure report quality and adherence to regulations, guidance, and agency deadlines.
• Develop, implement, and maintain regulatory standards and best practices for dossier management, publishing, and archiving and provide training to submission contributors.
• Partner with the Worldwide Regulatory Operations team for the selection and maintenance of US Regulatory Operations software, hardware, electronic gateways, CTD templates and submission technology and serve as a resource for technology usage and training.
• Serve as interface between US Regulatory Operations and our external vendors and internal IT partners.
• Provide Project Management support for the PFP planned submissions.
• Implement process improvements for the US Regulatory Operation.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent with 5+ years’ experience in a pharmaceutical Regulatory Operations environment with emphasis on eCTD dossier management.
• Experience with Veeva Registrations, Submissions, Submissions Archive application, and PromoMats.
• Experience with Starting Point CTD templates and Share Point preferred.
• Understanding of SPL and XML in relationship to FDA drug listings, establishment registrations, and SAE reporting.
• Advanced user of MS Word, Excel, PowerPoint, and Adobe Acrobat.
• Extensive experience participating in cross-functional projects and teams.
• Rare diseases and/or oncology experience is highly desirable.
• Experience with biologics; cell or gene therapy experience is highly desirable.
• Scientific curiosity, creativity, and flexibility
• Ability to thrive in a fast-paced startup environment with high expectations.
• Ability to appropriately access and handle business information in compliance with all applicable laws, regulations and / or Pierre Fabre policies.
• A passion for making a difference in the lives of patients.

WORK ENVIRONMENT:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION: US, remoteBenefits of being a Pierre Fabre EmployeeJoin 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 FabrePierre Fabre has been recognized by Forbes as one of the “World’s Best Employers” for the 3rd year running.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.Who you are ?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.

Expected salary

Location

USA

Job date

Thu, 17 Oct 2024 07:04:30 GMT

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