Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

Apply locations US-Remote time type Full time posted on Posted 3 Days Ago job requisition id R00531

Ensure all your application information is up to date and in order before applying for this opportunity.

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.

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 is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio.

Job Duties and Responsibilities

• Leads preparation, coordination, authoring and monitoring of submissions (e.g., BLA / IND / NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests and interacts with Regulatory Operations to submit electronically.
• Represents GRA on less complex project related meetings and provides regulatory input as appropriate.
• Maintains development and post-marketing regulatory compliance by conducting global regulatory assessments of proposed changes to manufacturing processes and testing procedures.
• Tracks regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely, quality submissions.
• Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
• Maintains up-to-date knowledge of international and domestic regulatory requirements and best practices.
• Leads the documentation of regulatory interactions including decisions and outcomes.
• Collaborates effectively with Regulatory Operations Leader (ROL).
• Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing.
• Reviews CMC documentation (e.g. 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 quality and content of submissions to Health Authorities.

Key Core Competencies

Education and Experience

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.

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.

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.

J-18808-Ljbffr

Salary : $153,700 - $192,100