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Manager/Senior Manager, Regulatory Affairs, CMC Maidenhead United Kingdom,  

Posted on : 23 May 2017

Project Description

External Posting TitleManager/Senior Manager, Regulatory Affairs, CMC Job DescriptionThis 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 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 •Support and/or act as the global CMC regulatory contact with relevant regulatory authorities•Coordinate all CMC aspects of global regulatory submissions and submission strategy.*LI-EU4 LocationMaidenhead, UK Job CategoryRegulatory Requisition Number31537BR QualificationsA minimum of 6-10 years strategic global regulatory CMC, or relevant experienceKey Requirements:• Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.• Curiosity and passion for 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. Leadership/Management Skills:•Demonstrate effective cross functional and cross cultural skills including ability to impact industry/agency organization decisions.•Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively and demonstrate optimism and energy in the face of change and adversity.•Ability to work both independently with minimal direction and within project teams to attain group goals and key project milestones.•Ability to represent the department in project teams.•Demonstrate ability to assess and provide strategic guidance and impact organizational effectiveness including across cross functional teams. •Demonstrate strong skills to organize, prioritize, and execute.Regulatory Skills:•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 biologics and/or proteins. •Computer literate. EducationBA/BS/University degree in Life/Health Sciences required; advanced degree preferred. About BiogenCorporate Overview Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen 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). Biogen 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. Biogen was founded in 1978 and today serves patients in nearly 70 countries. A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion Global headquarters in Cambridge, MA, and international headquarters in Zug, Switzerland Our Science 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 Biogen 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, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders. Biogen is revolutionizing biologics manufacturing, developing the industry s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars 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. In 2015, we became a carbon neutral company and ranked first place on Newsweek s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Job Segment: Biotech, Product Development, Biology, Manager, R&D, Science, Research, Management


Maidenhead UK

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