Senior Manager, Global Regulatory Affairs, Marketed Products
Takeda
Summary
Takeda Development Center Americas, Inc. is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products to assist the Global Regulatory Lead (GRL) and work with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided to local company affiliates in compliance with local regulations and to maintain compliance for products.
Job description
- In collaboration with GRL, lead less complex multi-function submissions or support GRLs for more complex submissions.
- Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents, and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
- Assist the Global Regulatory Lead with Health Authority meetings and responses.
- Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize.
- Identify opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.
Up to 75% remote work is allowed. Up to 30% domestic travel required for business meetings and discussion.
Requirements
- Bachelor’s degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field
- 4 years of related experience
- Regulatory submissions to US FDA, EU, and other international health authorities
- Manage authoring, review cycles, finalization, and submission of Fast Track Designation Request to US FDA and Orphan Drug Designation request to EMA
- Oversee and manage all Regulatory activities related to ongoing clinical trials and ensure compliance with applicable regulations
- Author and manage review cycles for nonclinical regulatory content in submissions like Initial IBs and subsequent updates, briefing books, DSURs, Annual Reports, CTN, IND, CTA, PSP, PIP, 15-day safety notifications, and rapid response document
- Submission planning and management of Regulatory submissions
- Collaborate with cross-functional team members like Clinical Science, Safety, DSRE, DMPK, Clinical and nonclinical Pharmacology, Regulatory Operations, Publishing, and external teams
- Initiate reviews of regulatory documents, ensure cross-functional team engagement, and conduct comment resolution meetings
- Regulatory Intelligence: Perform regulatory analysis, competitor product research, and Probability of Regulatory Success (PRS) exercise
- Regulatory EDMS and business development support: provide end-user support for Regulatory electronic document management system (EDMS)
- Create job aids to simplify existing processes and improve adoption
- Represent Regulatory team on business development activities as needed
Benefits
- Medical, Dental & Vision Insurance
- 401(k)
- Paid Time Off
- Sick Leave
- Company Holidays
- Incentive Compensation Programs
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.