Sumitomo Pharma
VP, Regulatory Affairs R&D Biopharma
Sumitomo Pharma, Little Rock, Arkansas, United States, 72208
Overview
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn (LinkedIn URL). Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, reports to the Chief Development Officer for biopharma R&D. Responsible for providing leadership regulatory strategies for earliest possible approvals for the assets under Biopharma R&D. Focus
of Biopharma R&D is Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets. Responsibilities
Regulatory Strategy: Develop and manage Regulatory Affairs strategy; gain approval for regulatory strategies to meet the Companys objectives; oversee the execution of effective product registration pathways to bring products to market in a cost-effective and compliant manner; align regulatory strategies with SMP group business strategy; collaborate with Head of RA at SMP; provide oversight on global regulatory trends and anticipate regulatory impacts on the product portfolio; serve as senior expert on regulatory matters with external stakeholders, internal committees, and government entities globally; recommend and facilitate decision making on regulatory matters in partnership with the Chief Development Officer and other stakeholders; establish key business metrics to gauge RA productivity and efficiency; develop, present and manage RA budget and resource plan with regional centers and corporate planning; provide global guidance and monitoring of regulatory items in the clinical development budget; serve as the senior point of contact for internal communication; ensure development of launch materials and claims with Marketing, Medical, and Legal are guided by regulatory requirements; establish cross-functional regulatory education initiatives; oversee Regulatory operations and medical writing as appropriate; perform other duties as directed. Talent Management: Inspire and lead RA staff to attain goals; ensure global compliance with internal and external policies; promote a high performance, results-oriented culture; establish expectations and monitor performance; ensure resources support RA strategy and operations; promote a development-focused, accountable work environment. Regulatory Best Practices: Promote industry best practices aligned with Company culture; foster an interconnected RA operating culture; establish and ensure compliance to global SOPs; develop registration roadmaps with risk/opportunity awareness; manage the regulatory affairs budget focusing on cost-effectiveness and quality. Communications: Provide accurate and timely status updates on regulatory projects; escalate unresolved issues to executive leadership; steward communications with regulatory agencies to support favorable outcomes. Relationships: Build collaborative relationships with stakeholders; represent R&D decision committees as defined by company rules. Business Development: Support regulatory analysis and due diligence for BD and NPD activities; support regulatory filings and joint committee membership with strategic partners. Location and Travel: Candidate local to Marlborough, MA preferred but not required; primarily remote with periodic on-site meetings; willingness to travel domestically and internationally as needed. Requirements and Core Competencies
Education/Experience: Doctoral degree (MD, Pharm.D., or Ph.D.) with 20+ years in biotech/pharma, including at least 10 years of executive management in Regulatory Affairs; demonstrated leadership of early to late-phase compounds; experience with CBER as well as CDER; significant international experience. Core Competencies: Deep industry and regulatory acumen; strong understanding of global regulatory dynamics; high ethics and integrity; ability to align people, policies, and processes; motivational leadership for a global regulatory organization; ability to implement change and foster accountability; ability to manage multiple demands in a fast-paced environment; high initiative and independence; excellent written and oral communication skills. Education and Experience
Doctoral degree (MD, Pharm.D., or Ph.D.) with 20+ years of relevant experience in biotech or pharmaceutical industry and at least 10 years at an executive management level within Regulatory Affairs; demonstrated regulatory leadership from early to late-phase development; international experience required. Compensation and Benefits
The base salary range for this role is $280,560 to $350,700. Base salary is part of our total rewards package, including merit-based increases, eligibility for the 401(k) plan, medical/dental/vision/life/disability insurances, and a comprehensive time-off policy (flexible paid time off, 11 paid holidays, December shutdown, and 80 hours of paid sick time annually). Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Compliance and Equal Opportunity Disclaimer: The statements are intended to describe the general nature and level of work; not an exhaustive list of responsibilities. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, sexual orientation, disability, veteran status, or any other protected characteristic. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with applicable regulatory, legal, and operational rules and procedures. It is unlawful in Massachusetts to require a lie detector test as a condition of employment. #J-18808-Ljbffr
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn (LinkedIn URL). Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, reports to the Chief Development Officer for biopharma R&D. Responsible for providing leadership regulatory strategies for earliest possible approvals for the assets under Biopharma R&D. Focus
of Biopharma R&D is Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets. Responsibilities
Regulatory Strategy: Develop and manage Regulatory Affairs strategy; gain approval for regulatory strategies to meet the Companys objectives; oversee the execution of effective product registration pathways to bring products to market in a cost-effective and compliant manner; align regulatory strategies with SMP group business strategy; collaborate with Head of RA at SMP; provide oversight on global regulatory trends and anticipate regulatory impacts on the product portfolio; serve as senior expert on regulatory matters with external stakeholders, internal committees, and government entities globally; recommend and facilitate decision making on regulatory matters in partnership with the Chief Development Officer and other stakeholders; establish key business metrics to gauge RA productivity and efficiency; develop, present and manage RA budget and resource plan with regional centers and corporate planning; provide global guidance and monitoring of regulatory items in the clinical development budget; serve as the senior point of contact for internal communication; ensure development of launch materials and claims with Marketing, Medical, and Legal are guided by regulatory requirements; establish cross-functional regulatory education initiatives; oversee Regulatory operations and medical writing as appropriate; perform other duties as directed. Talent Management: Inspire and lead RA staff to attain goals; ensure global compliance with internal and external policies; promote a high performance, results-oriented culture; establish expectations and monitor performance; ensure resources support RA strategy and operations; promote a development-focused, accountable work environment. Regulatory Best Practices: Promote industry best practices aligned with Company culture; foster an interconnected RA operating culture; establish and ensure compliance to global SOPs; develop registration roadmaps with risk/opportunity awareness; manage the regulatory affairs budget focusing on cost-effectiveness and quality. Communications: Provide accurate and timely status updates on regulatory projects; escalate unresolved issues to executive leadership; steward communications with regulatory agencies to support favorable outcomes. Relationships: Build collaborative relationships with stakeholders; represent R&D decision committees as defined by company rules. Business Development: Support regulatory analysis and due diligence for BD and NPD activities; support regulatory filings and joint committee membership with strategic partners. Location and Travel: Candidate local to Marlborough, MA preferred but not required; primarily remote with periodic on-site meetings; willingness to travel domestically and internationally as needed. Requirements and Core Competencies
Education/Experience: Doctoral degree (MD, Pharm.D., or Ph.D.) with 20+ years in biotech/pharma, including at least 10 years of executive management in Regulatory Affairs; demonstrated leadership of early to late-phase compounds; experience with CBER as well as CDER; significant international experience. Core Competencies: Deep industry and regulatory acumen; strong understanding of global regulatory dynamics; high ethics and integrity; ability to align people, policies, and processes; motivational leadership for a global regulatory organization; ability to implement change and foster accountability; ability to manage multiple demands in a fast-paced environment; high initiative and independence; excellent written and oral communication skills. Education and Experience
Doctoral degree (MD, Pharm.D., or Ph.D.) with 20+ years of relevant experience in biotech or pharmaceutical industry and at least 10 years at an executive management level within Regulatory Affairs; demonstrated regulatory leadership from early to late-phase development; international experience required. Compensation and Benefits
The base salary range for this role is $280,560 to $350,700. Base salary is part of our total rewards package, including merit-based increases, eligibility for the 401(k) plan, medical/dental/vision/life/disability insurances, and a comprehensive time-off policy (flexible paid time off, 11 paid holidays, December shutdown, and 80 hours of paid sick time annually). Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Compliance and Equal Opportunity Disclaimer: The statements are intended to describe the general nature and level of work; not an exhaustive list of responsibilities. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, sexual orientation, disability, veteran status, or any other protected characteristic. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with applicable regulatory, legal, and operational rules and procedures. It is unlawful in Massachusetts to require a lie detector test as a condition of employment. #J-18808-Ljbffr