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 Associate Director, Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio. Depending on the candidate’s skill-set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage projects and/or commercial asset such as Gemtessa® or Aptiom® (i.e., at least 5 years post-launch). This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products.

This position has a moderate-high level of autonomy but may require some coaching and mentoring.

Job Duties and Responsibilities

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)

• Ensures execution of regional regulatory plans in line with the global registration strategy in collaboration with the global regulatory leader (GRL)

• Leads preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests and interacts with Regulatory Operations to submit electronically

• Represents GRA on less complex project related meetings and provides regulatory input as appropriate

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

• Leads the documentation of regulatory interactions including decisions and outcomes

• Provides updates at the GRT 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 quality and content of submissions to Health Authorities

• Depending on skill-set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaison with local Health Authority and company governance boards for assigned projects

• Depending on the skill-set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities

• Assist with development of the global regulatory functional plan through the 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

• Depending on the skill-set, ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level

Promotional Activities

• Participates in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in advertising and promotion

• Conducts regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, Health Authority regulations, ICH guidelines, PhRMA guidelines, company policies and established precedents and recommends revisions/actions that balance risks and opportunities.

• In collaboration with the Regulatory Operations Leader (ROL), ensures all submissions to the Office of Prescription Drug Promotion (OPDP) are complete and presented to facilitate agency review.

Key Core Competencies

• Strong verbal and written communication, interpersonal, listening, 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

• Solid 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

• Capable of effectively negotiating with others while maintaining composure

• Experience interacting with the FDA

• Experience in successfully leading teams

• Develop and prepare successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document in coordination with clinical plans and marketing objectives

• Proven success/major involvement in major submissions and approval

• 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.

Education and Experience

• Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline)

• 6 – 8 years relevant experience in biotech or pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs

• Include the qualifications preferred of the candidate to have but is not required to be considered for the role.

The base salary range for this role is $153,700 to $192,100. 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