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Manager/Sr Manager, Global Regulatory CMC (Pharmaceuticals) Cambridge United States,  

Posted on : 01 May 2017

Project Description

External Posting TitleManager/Sr Manager, Global Regulatory CMC (Pharmaceuticals) 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 early and late phase pharmaceutical and life-cycle management activities for small molecules/pharmaceuticals and antisense oligonucleotides (ASO) and innovative regulatory CMC approaches:• Lead the development, implementation, and influence of CMC regulatory strategy •Identify and assess global regulatory risks• Develop global agency meeting strategies• Serve as the global regulatory representative on relevant project teams• Act as the primary global regulatory contact with relevant regulatory authorities• Coordinate all CMC aspects of global regulatory submissions.*LI-POT1 LocationCambridge, MA, US Job CategoryRegulatory Requisition Number30290BR QualificationsA minimum of 5-10 years strategic global regulatory CMC, or relevant experience.Key Requirements:• Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.• 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.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, committees, etc. 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 INDs/CTAs, license applications, supplements/variations, and amendments.• Knowledge and understanding of applicable global regulations.• Experience and knowledge in pharmaceutical, oligonucleotide, and gene/cell therapy drug development; experience in biologics and/or proteins a plus.• Computer literate. EducationBA/BS/University degree in Life/Health Sciences required; advanced degree preferred. About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer s Disease, amyotrophic lateral sclerosis (ALS), Parkinson s disease, spinal muscular atrophy and neuropathic pain amongst others. With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. 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. Nearest Major Market: Cambridge Nearest Secondary Market: Boston Job Segment: Biotech, Pharmaceutical, Manager, R&D, Science, Management, Research


Cambridge, MA, US

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