Associate Director, Regulatory Affairs

Associate Director Regulatory Affairs

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. The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He / she will primarily function as the Regional Regulatory Leader (RRL) and / or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train / mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring.

Job Duties and Responsibilities

Manage and Develop Talent + May train / mentor junior staff

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)
• As a part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product
• Competently represent GRA on project team meetings
• Lead and coordinate 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
• Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
• Leads documentation of regulatory authority interactions including decisions and outcomes
• Provides updates at the Global Regulatory Team 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 the quality and content of all submissions to Health Authorities
• Leads the regional health authority meetings, liaison with local Health Authority
• Document owner of 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
• Accountable in conjunction with the GRL as applicable for developing and maintaining the development core data sheet (DCDS) if required
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
• Provide strategic review of dossier summaries, expert statements, and development management plans
• Provide updates to the GRT, project teams, and governance boards as needed
• Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
• May be responsible for creating and reviewing SOPs and regulatory department operating procedures

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

Experience contributing to electronic regulatory submissions and working with regulatory templates

Advanced understanding of medical terminology, and FDA and ICH regulations / guidance 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

Proven success / major involvement in NDA / MAA / CTD submissions and approval

Capable of effectively negotiating with others while maintaining composure

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

Ability to learn new therapeutic areas when necessary

Prior history with post-marketing / brand optimization strategies and commercial awareness

Experience interacting with the FDA and ex-US Health Authorities

Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings

Ability to make complex decisions and willingness to defend difficult positions

Comfortable presenting to all levels of the organization including Senior Management

High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture

Education and Experience

Bachelor's degree in a related field required.

Master's degree required (preferably in a scientific discipline)

Approximately 7 years of prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs

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.

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. 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.

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