Sr Manager, Regulatory Affairs - United States
This position is in the Global Regulatory CMC group and is focused on the development and execution of global regulatory CMC strategies with a focus on commercial and late stage development programs and innovative regulatory approaches:
- Lead the development, implementation, and influence of CMC regulatory strategy.
- Identify and assess global regulatory risks and mitigations
- Develop global agency meeting engagement plans
- Represent regulatory on relevant project teams
- Support and/or act as the global regulatory contact with relevant regulatory authorities
- Coordinate all CMC aspects of global regulatory submissions and submission strategy
A minimum of 6-10 years strategic global regulatory CMC, or relevant experience
- Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
- Curiosity and passion for science and new manufacturing technologies
- Strong interpersonal skills and the ability to deal effectively with a variety of business areas including R&D, quality, compliance, technical development, process chemistry, manufacturing, and external partners/collaborators.
- A passion for product development and the patients who we serve.
- Experience in interfacing with relevant global regulatory authorities.
- Experience and knowledge in the preparation of major global regulatory submissions including license applications, supplements/variations, and amendments.
- Knowledge and understanding of applicable global regulations.
- Experience and knowledge in biologic and/or proteins.
- Bachelor's degree required, preferably in Life/Health Sciences
- Advanced degree preferred
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.