Senior Manager, Regulatory Affairs CMC (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. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

We are currently seeking a dynamic, highly motivated, experienced individual for the position of Senior Manager, Regulatory Affairs CMC (Oncology). The Senior Manager is part of the Global Regulatory Affairs (GRA) team based in the US and will primarily function as a Regional Regulatory CMC Lead and supports the Global Regulatory CMC Leader with CMC regulatory strategies as requested.   

This position is responsible for assisting the Global Regulatory CMC Leader with preparation, coordination and monitoring of submissions, and responses to Health Authority (HA) information requests. This position may represent GRA on project team meetings, provide regulatory input as appropriate and lead the development of less complex regulatory documents. The role partners closely with CMC, Quality, Manufacturing, Supply Chain, Global Regulatory, Regulatory Operations and cross-functional project teams to support development, registration, post-approval lifecycle management and regulatory compliance. 

This position works with a moderate level of independence and autonomy and requires some coaching and mentoring.

Job Duties and Responsibilities

• Provides strategic guidance on regional CMC regulatory requirements for investigational and commercial products.
• Supports the development and execution of global and regional regulatory CMC strategies to support clinical development programs, marketing applications, and lifecycle management activities.
• Plans, coordinate, prepares, reviews, and supports the submission of CMC regulatory documentation and dossiers (Modules 2.3 and 3) for clinical and commercial products, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, and post-approval submissions.
• Leads the preparation and coordination of CMC responses to Health Authority information requests, deficiency letters, regulatory commitments, and other agency communications.
• Represents Regulatory Affairs CMC on cross-functional teams and collaborates with internal and external stakeholders to advance regulatory strategies and ensure successful execution of development, registration, and lifecycle management objectives.
• Maintains regulatory documentation and records in accordance with applicable regulatory requirements and company procedures to support compliance and inspection readiness.
• Assesses manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain changes for regulatory impact and supports development of appropriate global filing strategies.
• Supports Health Authority interactions, inspections, audits, due diligence activities, and regulatory meetings, including preparation of supporting documentation as needed.
• Contributes to continuous improvement initiatives, including development and enhancement of regulatory processes, procedures, templates, and best practices.
• Supports the global regulatory lead (GRL) and the global CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs
• Ensures compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinates regulatory compliance activities
• Contributes to regional health authority meetings, and briefing book documentation to Health Authorities
• Is 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
• 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
• Experience contributing to electronic regulatory submissions and working with regulatory templates
• Demonstrated ability to facilitate appropriate team decisions
• Sense of urgency and perseverance to achieve results
• Ability to understand issues, problems and opportunities by comparing data from different sources to draw conclusions and choose a course of action to develop appropriate solutions.
• Strong knowledge of eCTD elements and structure and regulatory writing skills.
• 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 6 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 3 years focused in regulatory affairs
• Established working knowledge of regulatory guidelines and regulations (US and international). Regulatory experience supporting both development projects and marketed products.
• Strong knowledge of eCTD elements and structure and regulatory writing skills.
• Prior experience with NDA/BLA submission is preferred.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. 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.

The base salary range for this role is

$156,000.00 - $195,000.00

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, in accordance with applicable law.

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.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

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.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.