Genzyme Corporation

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Global Regulatory Lead (GRL)

at Genzyme Corporation

Posted: 6/25/2020
Job Status: Full Time
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Job Description

Genzyme Corporation in Cambridge, MA seeks a Global Regulatory Lead (GRL) for its Global Regulatory Affairs (GRA) team: to dev. / facilitate global regulatory strategies & timelines for marketed products; to rep. GRA on global, cross-functional teams; to rev. & assemble docs for submissions to regulatory authorities; & to provide tech. rev. & ensure regulatory compliance. Salary offered: $125,000/year. Hours: 8:30 am-5pm, M-F. Employer offers: on-boarding training to all employees, training on internal sys. & policies, & training to maintain job-specific knowledge up to date. Employees are offered standard company benefits. Reqs include: no less than Bachelor's in regulatory affairs, or in a life sciences discipline, followed by 5 yrs of exp in job offered or 5 yrs of progressively responsible regulatory affairs exp in related industry; OR a Master's degree in regulatory affairs, or in a life sciences field, & 3 yrs of exp in job offered or of regulatory affairs exp. in related industry; or any suitable comb. of edu., training, or exp. but no less than a Bachelor's degree followed by 5 yrs of exp as described above. Also reqs: of total exp req, must have at least 1 yr exp developing, implementing & communicating regulatory strategy & managing HA requests; of total exp req. must have at least 1 yr of exp. leading & managing cross functional initiatives involving regulatory & other functional areas; knowledge of regs for drug & biological products in the US, EU & emerging markets; proficiency in MS Word, Excel, PowerPoint & MS Project; understanding scientific principals assocd. with regulatory submissions; ability to interpret regulatory reqs & accurately communicate them to technical functions within a business. Genzyme Corp. & its U.S. affiliates are Equal Opportunity & Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 

Application Instructions

To apply, send resumes to:  Recruitment & Employment Office, Genzyme Corporation, Attn:  Job Ref #:GEN65565  P.O. Box 56625  Atlanta, GA 30343.