Lifelancer
Associate Director, Regulatory Affairs
Lifelancer, Marlborough, Massachusetts, us, 01752
Job Title:
Associate Director, Regulatory Affairs Job Location:
United States Job Location Type:
Remote Job Contract Type:
Full-time Job Seniority Level:
Director Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe 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 Phases I-IV Research & Development Activities As a Regional Regulatory Lead, 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 in collaboration with the GRL. 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. Provide updates at the GRT meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions. Ensure quality and content of submissions to Health Authorities. Assist with development of the global regulatory functional plan. Promotional Activities Participate in the promotional materials review committee along with Marketing Brand Teams, Legal, Medical Affairs, and Clinical Research. Conduct regulatory review of promotional and non-promotional materials in accordance with business goals and objectives. 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, FDA and ICH regulations. Experience interacting with the FDA. Proven success in major submissions and approvals. 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 minimum of 6 years focused in Regulatory Affairs. The base salary range for this role is $153,700 to $192,100. Total compensation will depend on elements unique to each candidate. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, disability, veteran status or any other characteristic protected by law.
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Associate Director, Regulatory Affairs Job Location:
United States Job Location Type:
Remote Job Contract Type:
Full-time Job Seniority Level:
Director Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe 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 Phases I-IV Research & Development Activities As a Regional Regulatory Lead, 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 in collaboration with the GRL. 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. Provide updates at the GRT meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions. Ensure quality and content of submissions to Health Authorities. Assist with development of the global regulatory functional plan. Promotional Activities Participate in the promotional materials review committee along with Marketing Brand Teams, Legal, Medical Affairs, and Clinical Research. Conduct regulatory review of promotional and non-promotional materials in accordance with business goals and objectives. 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, FDA and ICH regulations. Experience interacting with the FDA. Proven success in major submissions and approvals. 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 minimum of 6 years focused in Regulatory Affairs. The base salary range for this role is $153,700 to $192,100. Total compensation will depend on elements unique to each candidate. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, disability, veteran status or any other characteristic protected by law.
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