Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Charleston, West Virginia, us, 25329
Sumitomo Pharma Associate Director, Regulatory Affairs Charleston, West Virginia Apply Now
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies.
Job Overview
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 a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL).
This position has a moderate-high level of autonomy but may require some coaching and mentoring.
Job Duties and Responsibilities
Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
Ensure execution of regional regulatory plans in line with the global registration strategy.
Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures) and responses to HA information requests.
Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
Review nonclinical, clinical and CMC documentation and contribute to content as needed.
Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research.
Key Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills.
Ability to work in a diverse environment.
Experience contributing to electronic regulatory submissions.
Solid understanding of medical terminology, and FDA and ICH regulations/guidances.
Education and Experience
Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs.
Compensation and Benefits
The base salary range for this role is $153,700 to $192,100, along with a comprehensive total rewards package.
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.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer.
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Job Overview
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 a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL).
This position has a moderate-high level of autonomy but may require some coaching and mentoring.
Job Duties and Responsibilities
Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
Ensure execution of regional regulatory plans in line with the global registration strategy.
Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures) and responses to HA information requests.
Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
Review nonclinical, clinical and CMC documentation and contribute to content as needed.
Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research.
Key Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills.
Ability to work in a diverse environment.
Experience contributing to electronic regulatory submissions.
Solid understanding of medical terminology, and FDA and ICH regulations/guidances.
Education and Experience
Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs.
Compensation and Benefits
The base salary range for this role is $153,700 to $192,100, along with a comprehensive total rewards package.
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.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer.
#J-18808-Ljbffr