Associate Director, Regulatory Affairs

Sumitomo Pharma Associate Director, Regulatory Affairs Phoenix, Arizona Apply Now

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.

Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.

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

• As a Regional Regulatory Lead, manage regional (United States and / or European) regulatory activities as part of a Global Regulatory Team (GRT).
• Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the global regulatory leader (GRL).
• 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 and interact with Regulatory Operations to submit electronically.
• Represent GRA on less complex project related meetings and provide regulatory input as appropriate.
• Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
• Lead the documentation of regulatory interactions including decisions and outcomes.
• Provide updates at the GRT meetings and project teams as needed.
• Collaborate effectively with Regulatory Operations Leader (ROL).
• Maintain professional working relationship with colleagues, fostering collaboration, and idea sharing.
• 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.
• Advise team members of major regulatory issues and provide possible solutions, and lead the mitigation strategy.
• Lead and coordinate local project team members in developing strategy for applicable documents / activities.
• Ensure 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.
• 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.

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.

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.

Compensation and Benefits

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.

Equal Employment Opportunity

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer. 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.

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Salary : $153,700 - $192,100