What are the responsibilities and job description for the Associate Director, Regulatory Affairs position at Lifelancer?
Job Title : Associate Director, Regulatory Affairs
While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.
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
Key Core Competencies
Education And Experience
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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Salary : $153,700 - $192,100
