Sumitomo Pharma America, Inc. · 5 hours ago
Vice President, Regulatory Affairs - Oncology
United States
Full-time
Remote
Director/Executive
$281K/yr - $351K/yr
15+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in oncology and other areas. They are seeking a Vice President of Regulatory Affairs Oncology to lead the development of regulatory strategies, manage submissions, and ensure compliance across the company's programs.
Pharmaceuticals
Responsibilities
Strategic thought partner including with but not limited to VP Clin Dev and CMO
Manage Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion of prescription drugs
Guide and/or lead regulatory agency interactions, including communications and meetings
Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion in accordance with business goals and objectives, regulations, guidelines, and company policy
Manage and/or support the development and implementation of policies, procedures and tools related to advertising, promotion, and labeling
Manage compliance and risks related to R&D activities, especially activities of regulatory affairs, (e.g., SOPs)
Set clear standards and expectations for the accurate and timely reporting of status of all regulatory affairs activities; provide relevant input to Leadership
Oversee the regulatory activities at CROs, providing document review in order to ensure the quality and scientific integrity of documents submitted to regulatory authorities
In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with FDA-approved labeling
Provide regulatory leadership to the respective cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance with FDA regulations and Company policies
Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses, and ad boards
Serve as primary contact leading and facilitating communications with the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials
Direct and ensure the timely submission of all applicable approved promotional materials to the FDA on Form 2253s
Ensure compliance of labeling, promotional and educational materials with governing Health Authorities
Managing responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for both women’s health and prostate cancer
Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals
Provide leadership and direction to clinical regulatory. Provide coaching and development and drive a culture of excellence that motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals
Qualification
Required
Deeply experienced in Oncology
Recent Oncology NDA submission experience
Experience with submissions worldwide including HTA submissions
Experience with supporting all aspects of global commercial product
Advanced degree in a relevant scientific discipline required
15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs in Oncology
Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs)
NDA Experience in Oncology required
Demonstrated leadership skill leading a functional team
Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional)
Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges
Preferred
Doctoral degree (MD, PharmD, or PhD) preferred
Benefits
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Leaves provided in line with your work state
Flexible paid time off
11 paid holidays plus additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
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