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 key operations in the U.S., Canada, and Europe 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.

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. The 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 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

Regulatory Best Practices

Communications

Build and Maintain Key Relationships

Business Development

Location and Travel

Key Core Competencies

Education and Experience

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.

Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental / Physical Requirements : 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. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status