Director, Regulatory Project Management

Your mission

Director, Regulatory Project Management

At 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 Director, Regulatory Project Management (DRPM) will lead the regulatory project management of regulatory affairs projects associated with Pierre Fabre Pharmaceutical US product portfolio and pipeline. The DRPM will work collaboratively with cross functional teams and lead the US regulatory team, the Worldwide Pierre Fabre Regulatory Affairs organizations, global stakeholders, R&D, Technical Operations, and SMEs through all project phases to support new product development, pre and post approval activities in the US. The DRPM should maintain knowledge of current international regulations/guidelines/policies applicable to Pierre Fabre’s products and pipeline. This position includes providing regulatory guidance and updates to internal and external stakeholders in line with defined regulatory plans. 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:

• Act as the Regulatory Project Manager lead on cross-functional regulatory projects across the entire lifecycle (Pre-Sub, Sub, Post-Sub, and Post-Approval) and ensure timely execution of project objectives in line with regulatory affairs (RA) team’s priorities.
• Manage the preparation, review, and submission of US regulatory filings, information request responses, change notifications, and post-market surveillance reports/compliance reports.
• Manage the implementation of US regulatory projects (process and systems)
• Independently analyze and track regulatory project progress against pre-defined milestones, develop integrated timelines, and be proactive in identifying and escalating project risks/technical gaps to leadership teams.
• Participate in regulatory planning and support the development of US regulatory strategies, with consideration of latest guidance documents and current state-of-art standards/regulations.
• Collaborate with regulatory lead(s), cross-functional project manager(s) and SMEs (Subject Matter Experts) in R&D, Quality, Clinical, Medical, Technical Operations and Global Pierre Fabre organizations to align on deliverables for global submissions, establish key regulatory positions, and to ensure product development and lifecycle management activities are performed in compliance with applicable regulatory requirements.
• Present and implement action plan(s) for regulatory risk remediation and submission issue resolution. Maintain issue logs/register(s) and manage risk mitigation efforts for the entire lifecycle of the project.
• Generate and maintain regulatory project charter(s) and/or project dashboard(s) that deliver informative performance metrics and other critical information to stakeholders.
• Prepare for and manage regulatory audits and inspections by authorities, ensuring all findings or nonconformities are timely addressed and submitted to authorities.
• Remain current on evolving regulations, guidelines, and industry trends to inform regulatory actions.
• Assist in the establishment and maintenance of infrastructure tools, procedures, systems for Regulatory Project Management (RPM) team.

REQUIRED EDUCATION AND EXPERIENCE:

• 10+ years of biotech/pharma required with 6+ years’ experience in regulatory project management.
• Bachelor’s degree required, post graduate degree.
• Extensive experience on regulatory project management for pharmaceutical products.
• Extensive experience in NDA/BLA regulatory pre and post approval activities.
• 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.
• Veeva knowledge and experience is a plus.
• Experience with Project Management systems and tools.
• 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, Remote

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 "World's Best Employers" for the 3rd year running. 

https://www.pierre-fabre.com/en-us 

True 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.