Description
Position at Seagen
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines.
As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells.
Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission.
By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world.
Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary :
The Senior Manager, Regulatory Affairs is an individual contributor role that supports a senior regulatory professional by executing against the global regulatory plan for one or more products.
This position represents Regulatory on cross-functional teams and leads the development and preparation of regulatory documentation to regulatory authorities.
Principal Responsibilities :
Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients
Ensure receipt of timely and actionable regulatory authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
Function as primary liaison with regulatory authorities, including providing complete and timely responses to regulatory authority requests for information
Assess regulatory program risks for likelihood and impact; establish mitigation strategies
Oversee the planning and preparation of submissions to regulatory authorities, related to INDs, CTAs, and marketing applications
Advise on regulatory requirements, expected outcomes, and changes to landscape
May provide guidance or coaching to other professionals
Other duties as assigned
Qualifications :
Demonstrates proficiency (teaches others, makes improvements) in key areas of responsibility, which is typically associated with Bachelor’s degree in a life sciences discipline and 6+ years of regulatory experience with drug or therapeutic biologic products in oncology
Proficient in :
Code of Federal Regulations Title 21 and FDA Guidance
Regional Health Authority Regulations and Guidance
Global Regulatory Expectations
Drug Development Process
Demonstrated ability to :
Develop and deliver multi-mode communications (., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences
Build partnerships and work collaboratively with others to meet shared objectives
Gain the confidence and trust of others through honesty, integrity, and authenticity
Actively learn through experimentation when tackling new problems, using both successes and failures as learning fodder
Secure and deploy resources effectively and efficiently
Operate effectively, even when things are not certain, or the way forward is not clear
Make good and timely decisions that keep the organization moving forward
See ahead to future possibilities and translate them into breakthrough strategies
The hiring pay range for this position is $136,000 - $176,000 per year based on skills, education and experience relevant to the role.
Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.
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