Director, Regulatory Affairs

Sumitomo Pharma

Frankfort (KY)

Remote

USD 196,000 - 245,000

Full time

11 days ago

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Job summary

Sumitomo Pharma Co., Ltd. in the US is seeking a seasoned Regulatory Leader to drive global and regional regulatory strategy for CNS assets. You will lead cross-functional teams, coordinate submissions, and navigate FDA/ICH guidelines to ensure compliant product development and approvals.

The role emphasizes autonomy, mentorship of junior staff, and active collaboration with Health Authorities across domestic and international programs. Strong leadership in regulatory strategy is essential.

Qualifications

Bachelor's degree in a related field.
Minimum 10 years of relevant experience in biotech or pharmaceutical industry.
Master's degree required (preferably in a scientific discipline).
Experience leading regulatory teams and interactions with Health Authorities.

Responsibilities

Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy.
As a Regional Regulatory Lead, manage regional regulatory activities as part of a Global Regulatory Team (GRT).
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations on electronic submissions.
Leads documentation of regulatory authority interactions including decisions and outcomes.
Provides updates at the Global Regulatory Team meetings and project teams as needed.

Skills

Regulatory strategy

Global/regional leadership

FDA/ICH guidance

Regulatory submissions

Cross-functional collaboration

Project management

Team leadership

Regulatory documentation

Communication skills

Education

Bachelor's degree in a related field

Master's degree

Job description

US-Remote

Full time

R01517

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.

Job Overview:

This position reports to Executive Director, Regulatory Affairs and is part of the Biopharma R&D Regulatory Affairs organization based in the US. The role is responsible for serving as the Global Regulatory Leader (GRL) and/or Regional Regulatory Leader (RRL) for assigned projects and works closely with cross‑functional teams to ensure effective collaboration and alignment.

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 CNS 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.

Essential Functions Required for Job:

Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy of the product
As a Regional Regulatory Lead, if applicable, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
Competently represents RA on project team meetings
Leads and coordinates project team members in developing regulatory strategy for applicable documents/ activities.
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations on electronic submissions
Assesses and communicates 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. summary documents, 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, if applicable, for developing and maintaining the development core data sheet (DCDS) and company core data sheet (CCDS) 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.

Knowledge, Skills and Abilities (general & technical):

Strong verbal and written communication skills; interpersonal skills; listening skills; organizational skills; and attention to detail 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/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
Proven success/major involvement in pre-IND/IND/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
Experience in CNS development and 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 & Experience Requirements:

Bachelor’s degree in a related field required.
Minimum 10 years of relevant experience in biotech or pharmaceutical industry
Master’s degree required (preferably in a scientific discipline)

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.

People Management:

This is an individual contributor role and does not have direct reports or formal people‑management responsibilities.

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:

The base salary range for this role is

$195,900.00 - $244,900.00

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 reasonableaccomodations@us.sumitomo-pharma.com . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

SMPA may use Artificial Intelligence (“AI”) as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

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