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. For more information on SMPA, visit our website / us. sumitomo-pharma. com (/c212. net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2F us. sumitomo-pharma. com%2F&a=https%3A%2F%2F us. sumitomo-pharma. com+) or follow us on LinkedIn (/c212. net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2F 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 .