Sumitomo Pharma
VP, Regulatory Affairs R&D Biopharma
Sumitomo Pharma, Washington, District of Columbia, us, 20022
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. Job Overview: We are seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads Regulatory Affairs for biopharma R&D and reports to the Chief Development Officer for biopharma R&D. Responsible for providing leadership on regulatory strategies for earliest possible approvals for assets under Biopharma R&D. Focus of Biopharma R&D includes Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets. Responsibilities
Regulatory Strategy: Develop and manage Regulatory Affairs strategy; gain approvals for regulatory strategies to meet the company’s objectives; oversee the execution of efficient 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 evaluation and analysis of global regulatory trends and anticipate impacts on the product portfolio; serve as the resident senior expert on regulatory matters with external stakeholders, internal committees, business partners, and government entities globally; recommend and facilitate decision making on regulatory matters with the Chief Development Officer and other stakeholders; establish metrics to gauge RA productivity and efficiency; manage RA budget and resource plan with regional centers and corporate planning; provide global guidance on regulatory line items in clinical development budgets; act as senior point of contact for internal communication; ensure development of launch materials/new claims with Marketing, Medical, and Legal guided by regulatory requirements; promote regulatory education across functions; oversee Regulatory operations and medical writing; perform other duties as directed.
Talent Management: Inspire and lead RA staff to achieve goals; ensure global compliance with policies and regulations; promote a high-performance, results-oriented culture; establish clear expectations and monitor performance; plan resources to support RA strategy and operations; foster employee development, accountability, proactive feedback, and high performance standards.
Regulatory Best Practices: Promote industry best practices aligned with the company culture; foster an interconnected RA operating culture; ensure global SOPs and practices across all regulatory phases; develop regulatory pathways with a clear registration roadmap and risk/opportunity assessment; manage the regulatory affairs budget focusing on cost-effectiveness and quality.
Communications: Provide accurate and timely reporting on regulatory projects and escalate unresolved issues to executive leadership; steward communications with regulatory agencies to support favorable registration outcomes.
Relationships: Develop collaborative relationships with key stakeholders; represent R&D decision committees as defined by company rules.
Business Development: Support regulatory analysis and due diligence for BD and New Product Planning; assist regulatory filings and participate in joint committee membership with strategic partners.
Location and Travel: Candidate local to Marlborough, MA is preferred but not required. Primarily remote with periodic on-site meetings; travel domestically and internationally as needed.
Qualifications
Education: Doctoral degree (MD, Pharm.D., or Ph.D.) with 20+ years of relevant biotech/pharmaceutical experience and at least 10 years in executive regulatory affairs leadership; demonstrated regulatory leadership from early to late-phase compounds; experience with CBER and CDER; substantial international experience in multicultural, multi-regional environments.
Key Core Competencies
Strong regulatory acumen and ability to develop strategies and operational plans addressing company interests.
Deep understanding of global regulatory dynamics; high ethics and integrity aligned with SMPA values.
Ability to align people, policies, and processes to foster collaboration and sustain momentum through communication of mission and outcomes.
Motivational leadership to help the global regulatory organization understand the company’s strategy and future.
Ability to implement change and cultivate accountability and nimbleness in a fast-paced environment.
Excellent written and oral communication skills; high initiative and independence.
Education and Experience
As above: Doctoral degree with 20+ years of relevant experience and 10+ years in executive regulatory leadership; experience with early to late-phase regulatory leadership; international experience required.
Compensation and Benefits
The base salary range for this role is $280,560 to $350,700. Base salary is part of the total rewards package including merit-based increases, 401(k), medical/dental/vision/life and disability insurances, and leave policies. Total compensation depends on candidate experience and other factors. The description includes standard compliance, confidentiality, and equal employment opportunity statements as applicable. Disclaimer: Statements describe the general nature and level of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered without regard to protected characteristics as defined by law.
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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. Job Overview: We are seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads Regulatory Affairs for biopharma R&D and reports to the Chief Development Officer for biopharma R&D. Responsible for providing leadership on regulatory strategies for earliest possible approvals for assets under Biopharma R&D. Focus of Biopharma R&D includes Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets. Responsibilities
Regulatory Strategy: Develop and manage Regulatory Affairs strategy; gain approvals for regulatory strategies to meet the company’s objectives; oversee the execution of efficient 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 evaluation and analysis of global regulatory trends and anticipate impacts on the product portfolio; serve as the resident senior expert on regulatory matters with external stakeholders, internal committees, business partners, and government entities globally; recommend and facilitate decision making on regulatory matters with the Chief Development Officer and other stakeholders; establish metrics to gauge RA productivity and efficiency; manage RA budget and resource plan with regional centers and corporate planning; provide global guidance on regulatory line items in clinical development budgets; act as senior point of contact for internal communication; ensure development of launch materials/new claims with Marketing, Medical, and Legal guided by regulatory requirements; promote regulatory education across functions; oversee Regulatory operations and medical writing; perform other duties as directed.
Talent Management: Inspire and lead RA staff to achieve goals; ensure global compliance with policies and regulations; promote a high-performance, results-oriented culture; establish clear expectations and monitor performance; plan resources to support RA strategy and operations; foster employee development, accountability, proactive feedback, and high performance standards.
Regulatory Best Practices: Promote industry best practices aligned with the company culture; foster an interconnected RA operating culture; ensure global SOPs and practices across all regulatory phases; develop regulatory pathways with a clear registration roadmap and risk/opportunity assessment; manage the regulatory affairs budget focusing on cost-effectiveness and quality.
Communications: Provide accurate and timely reporting on regulatory projects and escalate unresolved issues to executive leadership; steward communications with regulatory agencies to support favorable registration outcomes.
Relationships: Develop collaborative relationships with key stakeholders; represent R&D decision committees as defined by company rules.
Business Development: Support regulatory analysis and due diligence for BD and New Product Planning; assist regulatory filings and participate in joint committee membership with strategic partners.
Location and Travel: Candidate local to Marlborough, MA is preferred but not required. Primarily remote with periodic on-site meetings; travel domestically and internationally as needed.
Qualifications
Education: Doctoral degree (MD, Pharm.D., or Ph.D.) with 20+ years of relevant biotech/pharmaceutical experience and at least 10 years in executive regulatory affairs leadership; demonstrated regulatory leadership from early to late-phase compounds; experience with CBER and CDER; substantial international experience in multicultural, multi-regional environments.
Key Core Competencies
Strong regulatory acumen and ability to develop strategies and operational plans addressing company interests.
Deep understanding of global regulatory dynamics; high ethics and integrity aligned with SMPA values.
Ability to align people, policies, and processes to foster collaboration and sustain momentum through communication of mission and outcomes.
Motivational leadership to help the global regulatory organization understand the company’s strategy and future.
Ability to implement change and cultivate accountability and nimbleness in a fast-paced environment.
Excellent written and oral communication skills; high initiative and independence.
Education and Experience
As above: Doctoral degree with 20+ years of relevant experience and 10+ years in executive regulatory leadership; experience with early to late-phase regulatory leadership; international experience required.
Compensation and Benefits
The base salary range for this role is $280,560 to $350,700. Base salary is part of the total rewards package including merit-based increases, 401(k), medical/dental/vision/life and disability insurances, and leave policies. Total compensation depends on candidate experience and other factors. The description includes standard compliance, confidentiality, and equal employment opportunity statements as applicable. Disclaimer: Statements describe the general nature and level of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered without regard to protected characteristics as defined by law.
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