Associate Director, Regulatory Affairs

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.

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

1. Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
2. Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the global regulatory leader (GRL).
3. Lead 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.
4. Represent GRA on less complex project related meetings and provide regulatory input as appropriate.
5. Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
6. Lead the documentation of regulatory interactions including decisions and outcomes.
7. Provide updates at the GRT meetings and project teams as needed.
8. Collaborate effectively with Regulatory Operations Leader (ROL).
9. Maintain professional working relationship with colleagues, fostering collaboration and idea sharing.
10. Review 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.
11. Advise team members of major regulatory issues and provide possible solutions, and lead the mitigation strategy.
12. Lead and coordinate local project team members in developing strategy for applicable documents/activities.
13. Ensure quality and content of submissions to Health Authorities.
14. Depending on 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

1. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion.
2. Conduct 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.
3. In collaboration with the Regulatory Operations Leader (ROL), ensure all submissions to the Office of Prescription Drug Promotion (OPDP) are complete and presented to facilitate agency review.

Key Core Competencies

1. Strong verbal and written communication, interpersonal, listening, and organizational skills required.
2. Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values.
3. Ability to work in a diverse environment.
4. Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization.
5. Demonstrated ability to facilitate appropriate team decisions.
6. Experience contributing to electronic regulatory submissions and working with regulatory templates.
7. Solid understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry.
8. Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed.
9. Experience interacting with the FDA.
10. Experience in successfully leading teams.
11. Ability to learn new therapeutic areas when necessary.

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.

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.

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 or any other characteristic protected by law.

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