Sumitomo Pharma America, Inc. · 3 hours ago
Associate Director, Regulatory Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$156K/yr - $195K/yr
6+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health sectors. They are seeking an Associate Director, Regulatory Affairs CMC to provide regulatory CMC support throughout the development and registration processes of their product portfolio.
Pharmaceuticals
Responsibilities
Lead the planning and preparation of standalone CMC submissions and response to health authority (HA) inquiries
Define submission strategies and content; identify regulatory approval risks and propose mitigation plans. Provide authoring support as needed
Reviews CMC components of relevant documents and contribute to content development as appropriate
Represent Regulatory CMC in cross-functional meetings and collaborate with internal and external stakeholders on assigned projects
Partner with Quality and other functions to assess the regulatory impact of proposed changes to clinical materials and commercial products
Support the review of CMC reports, cGMP documents as part of global regulatory submissions packages
Stay current with international and domestic regulatory requirements and best practices. Provide guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices
Collaborate with Regulatory Operations to ensure submissions meet agreed timelines and established standards
Keep line management and key stakeholders updated on developments that may affect submission timelines or HA approvals
Foster a collaborative and professional working environment that promotes idea sharing and teamwork
Contribute to process improvements through cross-functional initiatives related to CMC submissions
Qualification
Required
BS or MS in a scientific field (e.g. Chemistry or Biology); advanced degree preferred
8 – 12 years or 6 – 8 years (with MS degree) of relevant experience in biotech or pharmaceutical industry, with specific experience in regulatory CMC
Prior experience in lifecycle management within regulatory
Strong written, verbal, and interpersonal communication skills
Ability to thrive in a diverse and dynamic environment; adaptable to changing priorities and work effectively in a matrix organization
Experience managing and compiling Module 3 documentation
Expertise in CMC lifecycle management for drug substance and drug product, including support for process development, analytical testing, and scale-up for registrations
Solid understanding of US, EU, and Canada regulations, guidelines and regulatory processes for development and lifecycle maintenance
Preferred
Experience working within Veeva RIM system
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
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