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Sumitomo Pharma

Director, Regulatory Affairs

Sumitomo Pharma, Hartford, Connecticut, us, 06112

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Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of

Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. Responsibilities

Manage and Develop Talent — may train/mentor junior staff. Phases I-IV Research & Development Activities — as a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). Lead regulatory activities for assigned project(s) in line with the global registration strategy of the product as part of the Global Regulatory Team (GRT). Represent GRA on project team meetings and coordinate strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions; work closely with Regulatory Operations in electronic submissions. Assess regulatory requirements and ensure activities comply with applicable regulations and guidelines. Document regulatory authority interactions including decisions and outcomes; provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate with regulatory operations leader (ROL) and maintain professional working relationships; promote collaboration and idea sharing. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise on major regulatory issues, propose solutions, and lead mitigation strategies; coordinate local project team strategies for documents/activities. Ensure the quality and content of submissions to Health Authorities; lead regional health authority meetings and liaise with local Health Authorities. Own briefing book documentation for Health Authorities and support development of the global regulatory functional plan. Maintain development core data sheet (DCDS) if required; ensure compliance with global regulatory requirements and internal policies. Provide strategic review of dossier summaries, expert statements, and development management plans; update GRT, project teams, and governance boards as needed. Lead Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions; may be responsible for creating/reviewing SOPs and regulatory department operating procedures. Key Core Competencies

Strong verbal and written communication, interpersonal, listening, and organizational skills. Ethical integrity aligned with SMPA values; ability to work in a diverse environment; adaptability in a matrix organization. Ability to facilitate team decisions, sense of urgency, and perseverance to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates; advanced understanding of medical terminology and FDA/ICH regulations relevant to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation; ability to interpret diverse data and determine appropriate actions. Proven success in NDA/MAA/CTD submissions and approvals; strong negotiation skills; ability to develop regulatory strategies and write regulatory strategy documents. Ability to learn new therapeutic areas; experience with post-marketing/brand optimization and commercial awareness; experience with FDA and ex-US Health Authorities. Experience leading teams and managing Health Authority negotiations/meetings; ability to make complex decisions and defend difficult positions; comfortable presenting to Senior Management. High organizational awareness and ability to understand interdependencies and the big picture. Education and Experience

Bachelor’s degree in a related field required. 8–12 years with Master’s of relevant experience in biotech or pharmaceutical industry, with a minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits

The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation will depend on elements unique to each candidate, including experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not an exhaustive list of all responsibilities, duties, and skills required. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Compliance and Equal Opportunity

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran or military status, or other protected characteristics as required by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with operations in the U.S., Canada, and Europe, focused on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website at https://www.us.sumitomo-pharma.com. Follow us on LinkedIn for updates.

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