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Sumitomo Pharma Associate Director, Regulatory Affairs in Little Rock, Arkansas

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 https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.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 Regulatory Affairs is a member of the Regulatory Project team leading maintenance submissions to the IND / CTA / NDA, developing and maintaining project and content plans for complex submissions (IND / NDA) and overseeing Regulatory Operations activities including publishing, submitting and archiving of regulatory submissions and correspondence.

Job Duties and Responsibilities

Lead maintenance submissions to the IND / CTA / NDA

Leads preparation, coordination, authoring and monitoring of CTA / IND / NDA maintenance submissions (e.g., annual reports, investigator brochures, IND amendments)
Attend project team meetings to provide input into regulatory requirements and company standards for IND / CTA / NDA maintenance submissions.
Defines submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed to ensure submission readiness.
Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation.
Facilitates submission preparation via completion of forms and creation of cover letters.

Submissions Project Management

Creates and maintains regulatory content and project plans and timelines for major submission projects (INDs, NDAs).
In alignment with Program Management, maintains project timelines and provides updates to senior management.
On a regular basis, meets with authors / reviewers monitor status of document creation and finalization as per project / content plan.
In collaboration with GRL and CMC RA lead, provides updates on dossier compilation to IND / NDA team

Liaison to Reg Ops team / oversight of Reg Ops activities

Overseeing the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions. Managing the activities of external staff contracted to pre-publish, publish and dispatch health authority submissions and archive correspondence.
Represents RA Oncology on project teams for matters relating to electronic (and paper) submissions as assigned.
Advises and/or trains project teams on new requirements, along with proposals for implementation, through robust understanding of HA standards and procedures for regulatory submissions.
Leads the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group.
Other duties as assigned.

Key Core Competencies

Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as teamwork, and interpersonal skills.
Effective communication and presentation skills. Experience in leading local system or process improvement projects.
Foundational strategic thinking and problem-solving skills.
Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.
Working across cultures in a diverse environment.

Education and Experience

Bachelor’s degree required; advanced degree preferred.
10 + years’ experience in the regulatory environment in the biotechnology/ pharmaceutical industry.
Experience in regulatory operations and/or regulatory submission management for global submissions.
Experience working with vendors and clinical research organizations
Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW.
Robust understanding of FDA and other health agency regulations and guidance’s governing submission content and format.
Expert knowledge of regulatory electronic document management systems (Veeva)
Prior project management experience with NDA/BLA submissions and review is required including Experience with project management-related software and tools (i.e., MS Project, MS Office, SharePoint etc.).

The base salary range for this role is $153,700 to $192,100. 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 unlimited 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.

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) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All 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, gender identity or expression; 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.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law Poster Supplement

Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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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Sumitomo Pharma Associate Director, Regulatory Affairs in Little Rock, Arkansas

Sumitomo Pharma

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