VP, Regulatory Affairs R&D Biopharma

Vice President, Regulatory Affairs, Biopharma R&D

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational 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.

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, reporting 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.

Job Duties and Responsibilities

Regulatory Strategy

Develop and manage regulatory affairs strategy

Develop and gain approval for regulatory strategy to meet the company's objectives

Oversee the execution of the most effective product registration pathways to bring products to market in a cost-effective and highly compliant manner

Collaboratively ensure that regulatory strategies are aligned to the SMP group business strategy

Collaborate with the Head of RA at SMP appropriately

Provide oversight on evaluation and analysis of trends pertaining to government regulatory activities on a global basis and anticipate impacts that changing regulations will have on the company's product portfolio

Serve as the resident senior expert on all regulatory matters with key external stakeholders, internal steering / review committees, business partners, and government entities on a global basis

Recommend and facilitate decision making on all regulatory matters in close partnership with the Chief Development Officer and other key stakeholders

Establish key business metrics with market reference points to gauge RA productivity and efficiency

Develop, present and manage RA budget and resource plan in close partnership with regional operating centers, the corporate planning and other appropriate functional groups

Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process

Serve as the senior point of contact for internal communication

Ensure that development of launch materials / new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements

Establish strong education / awareness of regulatory requirements cross functionally through comprehensive education initiatives

Oversees regulatory operation and medical writing team as appropriately

Perform other duties as directed

Manage and Develop Talent

Inspire and lead RA staff to ensure attainment of established goals and objectives

Ensure global compliance with all relevant internal and external policies and regulations applicable to drug development and regulatory approval

Promote a high performance results oriented collaborative work culture

Establish clear expectations, and monitor delivery of excellent performance

Establish resource plan to ensure that RA strategy and operational plans are appropriately resourced to support the company's business imperatives

Promote work environment that includes employee development, accountability, proactive feedback and high performance standards

Regulatory Best Practices

Promote and integrate industry best practices that fit well with the company's operating culture

Promote a highly interconnected RA operating culture

Establish and oversee compliance to global SOPs and work practices governing all phases of the regulatory process

Ensure that regulatory pathways are developed to deliver well planned registration roadmap with full understanding of the risks and opportunities

Develop and manage the regulatory affairs budget with a focus on cost-effectiveness, efficiency and maintenance of quality

Communications

Accurate and timely reporting status regulatory projects; escalate unresolved issues to appropriate executive leadership

Steward communications with regulatory agencies to ensure favorable registration outcome

Build and Maintain Key Relationships

Develop highly collaborative and responsive relationships with key stakeholders

Represent R&D decision committees defined as company rules

Business Development

Support Business Development and New Product Planning and assessment activities specifically related to regulatory analysis and due diligence. Also support regulatory filings and joint committee membership with strategic partners

Location and Travel

Candidate local to the Marlborough, MA is preferred, not required. Primarily remote role with periodic on-site meetings in office.

Must be able to travel domestically and internationally as needed.

Key Core Competencies

Highly developed industry and regulatory acumen with the ability to formulate strategies and operational plans that address the interests of the company

Highly developed understanding of global regulatory dynamics

Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values

Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through continual communication of group mission and team based outcomes

Ability to provide motivational leadership to help the global regulatory organization understand the company's strategy and future

Ability to shape and implement and sustain change efforts and instill a culture of accountability and nimbleness

Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary

Requires a high level of initiative and independence

Excellent written and oral communication skills required

Education and Experience

Doctoral degree (MD, Pharm.D. or Ph.D.) with 20+ years of relevant experience in biotech or pharmaceutical industry with at least 10 years of executive management level experience within Regulatory Affairs

Demonstrated regulatory leadership of early phase to late phase compounds

Experience with CBER not only CDER

Significant international experience working in multicultural and multi-regional environments is required

The base salary range for this role is $280,560 to $350,700. 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, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer : The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.