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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This position may train/mentor junior staff.

This position works with a high level of autonomy and requires limited coaching and mentoring.

Job Duties and Responsibilities

• Manage and Develop Talent

• May train/mentor junior staff

• Phases I-IV Research & Development Activities

• As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)

• As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product

• Competently represents GRA on project team meetings

• Leads and coordinates project team members in developing strategy for applicable documents/ activities.

• Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission

• Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines

• Leads documentation of regulatory authority interactions including decisions and outcomes

• Provides updates at the Global Regulatory Team meetings and project teams as needed

• Collaborates effectively with regulatory operations leader (ROL)

• Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing

• Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed

• Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy

• Leads and coordinates local project team members in developing strategy for applicable documents/activities

• Ensures the quality and content of all submissions to Health Authorities

• Leads the regional health authority meetings, liaison with local Health Authority,

• Document owner of briefing book documentation to Health Authorities

• Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling

• Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required

• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level

• Provide strategic review of dossier summaries, expert statements, and development management plans

• Provide updates to the GRT, project teams, and governance boards as needed

• Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions

• May be responsible for creating and reviewing SOPs and regulatory department operating procedures.

Key Core Competencies

• Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required

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

• Ability to work in a diverse environment

• Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization

• Demonstrated ability to facilitate appropriate team decisions

• Sense of urgency and perseverance to achieve results

• Experience contributing to electronic regulatory submissions and working with regulatory templates

• Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry

• Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed

• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution

• Proven success/major involvement in NDA/MAA/CTD submissions and approval

• Capable of effectively negotiating with others while maintaining composure

• Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document

• Ability to learn new therapeutic areas when necessary

• Prior history with post-marketing/brand optimization strategies and commercial awareness

• Expertise on regulations governing promotion and advertising of assigned products

• Experience interacting with the FDA and ex-US Health Authorities

• Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings

• Ability to make complex decisions and willingness to defend difficult positions.

• Comfortable presenting to all levels of the organization including Senior Management.

• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture

Education and Experience

• 8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.

• Master’s degree required (preferably in a scientific discipline)

The base salary range for this role is $183,000 to $228,800. 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 unlimited 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.

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) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All 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; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law Poster Supplement

Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas