Sr Manager, Regulatory CMC, Gene Therapy Portfolio - United States
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|External Posting Title||Sr Manager, Regulatory CMC, Gene Therapy Portfolio|
|Job Description||Biogen is searching for a highly motivated and experienced regulatory professional to join its Regulatory Affairs-CMC department. The successful candidate will be primarily responsible for development and execution of regulatory-CMC strategies for assets within Biogen’s growing portfolio of gene therapy programs.|
• Leading regulatory-CMC efforts on early-stage gene therapy assets, ensuring alignment of global regulatory requirements and expectations with both process development/manufacturing strategies and clinical development plans
• Serving as global regulatory-CMC representative on both internal project teams and joint CMC teams alongside peers from external partners;
• Identifying and assessing global regulatory risks for gene therapy assets and developing effective mitigation strategies in conjunction with internal stakeholders and external partners
• Developing and implementing global regulatory readiness plans for gene therapy assets, from formal agency interactions (pre-IND, Type B/C meetings, Scientific Advice meetings) to regulatory submissions (IND, CTA, and BLA/MAA)
• Contributing to regulatory engagement efforts and developing regulatory intelligence pertaining to critical aspects of gene therapy drug product manufacturing and quality
• Coordinating CMC aspects of global regulatory submission authoring and reviewing for gene therapy assets, both internally and in conjunction with partners.
|Location||Cambridge, MA, US|
|Qualifications||The ideal candidate should have a minimum of 7 years’ experience in strategic global regulatory CMC, with a strong preference for those having significant experience working on regulatory aspects of manufacturing and quality of viral vector gene therapy products. Job title will be commensurate with experience.|
• Demonstrated ability to develop, propose, and execute a globally-oriented regulatory-CMC strategy for a biopharmaceutical asset from clinical development to licensure
• Experience in interfacing with relevant global regulatory authorities, especially with respect to gene therapy products
• Experience and knowledge in the preparation of CMC content for major global regulatory submissions including INDs, CTAs, license applications, and meeting briefing packages
• Experience in representing the regulatory perspective on cross-functional project teams
• Demonstrate effective cross-functional and cross-cultural skills to successfully drive regulatory strategies in US, EU, Japan, and other emerging markets
• Ability to collaborate with Biogen Regulatory-CMC regional leads to realize ex-US objectives for gene therapy assets
• Demonstrate strong communication and influencing skills, both internally and externally with peers in other departments and at partner organizations
• Strong interpersonal skills and the ability to deal effectively with diverse stakeholders, including R&D, Global Quality, Engineering & Technology, Global Manufacturing, and external partners/collaborators
• Ability to work both independently with minimal direction, and within project teams and committees to attain group goals and key project milestones
|Education||BA/BS/University degree in Life/Health Sciences required; advanced degree preferred.|
|About Biogen||Corporate 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.
One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.
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 "@biogen.com" email accounts.
Nearest Major Market: Cambridge
Nearest Secondary Market: Boston
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