Regulatory Affairs Strategy Expert
6 days ago
About Daiichi Sankyo Inc.
">Daiichi Sankyo Inc. is a global pharmaceutical innovator dedicated to addressing diversified, unmet medical needs of people globally by leveraging its world-class science and technology. With over 100 years of scientific expertise and a presence in more than 20 countries, the company and its 16,000 employees draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Mission and Vision
This role offers the opportunity to contribute substantially to the mission of Daiichi Sankyo in leveraging our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. The company is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Description
The successful candidate will be responsible for developing and implementing effective regulatory strategies to deliver on efficient and robust development plans. This involves directing, coordinating, and implementing the preparation of US regulatory submissions and providing US regulatory support across all global projects; meeting aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.
Key Responsibilities:
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- Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.">
- Serve as the primary contact with FDA and liaise, negotiate, and orchestrate meetings and teleconferences with FDA.">
- Lead and prepare FDA submissions, including briefing documents, breakthrough therapy designation requests, orphan drug applications.">
- Participate in global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.">
- May serve as the single regulatory representative on study teams.">
- Review and interpret regulatory guidelines.">
Competencies and Qualifications
">The ideal candidate will have at least 10 years of experience in the pharmaceutical industry, with 8 or more years in regulatory affairs. A Bachelor's Degree is required, while an advanced degree (e.g., Master's, PharmD., Ph.D., MD, JD) is preferred. The successful candidate will also possess excellent oral and written communication skills, strong interpersonal skills, and the ability to work in a team environment. Additionally, they must be proactive, disciplined, organized, and detail-oriented, with the ability to think logically and objectively when identifying significant problems and opportunities.
Travel Requirements
The role may require occasional travel up to 30%, both domestically and internationally. Candidates should be able to adapt to changing priorities and meet deadlines in a high-pressure environment.
About Daiichi Sankyo Inc.
Daiichi Sankyo Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Estimated Salary: $120,000 - $180,000 per year
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