Associate Director, Regulatory Affairs (Oncology)

Associate Director, Regulatory Affairs (Oncology)

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Regulatory Affairs (Oncology). 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 / or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and / or global regulatory submissions and responses to health authority (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring.

Job Duties and Responsibilities

As a Regional Regulatory Lead, manage regional (United States, European and / or ROW) 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.

Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs.

Supports and / or leads documentation of regulatory authority interactions including decisions and outcomes.

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.

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

Provide updates to the Global Regulatory Team, project teams, and governance boards as needed.

Maintains professional working relationships 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 potential regulatory issues and provides possible solutions and mitigation strategy.

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

Contributes to regional health authority meetings, and 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.

Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed.

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.

Understanding of medical terminology, and FDA and ICH regulations / guidance documents 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.

Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document.

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

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

Education and Experience

Bachelor's degree in a related field required, preferably in a scientific discipline.

At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; ideally with a minimum of 4 years focused in regulatory affairs.

Oncology product development experience preferred.

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

Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials.

The base salary range for this role is $156,000 to $195,000. 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 flexible 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.

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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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) employer. 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; 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.