Sumitomo Pharma America, Inc. · 21 hours ago
Associate Director, Regulatory Affairs (Oncology)
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$156K/yr - $195K/yr
7+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in oncology and other therapeutic areas. The Associate Director, Regulatory Affairs will lead regulatory activities for assigned products, ensuring compliance with global regulatory requirements and coordinating submissions to health authorities.
Pharmaceuticals
Responsibilities
As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs
Supports and/or leads documentation of regulatory authority interactions including decisions and outcomes
Leads and coordinates project team members in developing strategy for applicable documents/ activities
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
Provide updates to the Global Regulatory Team, project teams, and governance boards as needed
Maintains professional working relationships with colleagues, fostering collaboration, and idea sharing
Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
Advises team members of potential regulatory issues and provides possible solutions and mitigation strategy
Ensures the quality and content of all submissions to Health Authorities
Contributes to regional health authority meetings, and briefing book documentation to Health Authorities
Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed
Qualification
Required
Bachelor's degree in a related field required, preferably in a scientific discipline
At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
Demonstrated ability to facilitate appropriate team decisions
Sense of urgency and perseverance to achieve results
Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry
Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
Ability to make complex decisions and willingness to defend difficult positions
Comfortable presenting to all levels of the organization including Senior Management
Preferred
Oncology product development experience preferred
Experience contributing to electronic regulatory submissions and working with regulatory templates
Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials
Benefits
Opportunity for 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
Company data provided by crunchbase