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Reference # : 17-00442 Title : Regulatory Affairs Manager
Location : Juncos, PR
Position Type : Full Time/Contract
Experience Level : 5 Years Start Date / End Date : 05/08/2017 / 05/31/2019  
Description
Regulatory experience with biotechnology products • Regulated industry, science or GMP practice experience • Understanding of drug development or drug commercial process • Experience in the development, review and maintenance of global regulatory dossiers. • Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies. • Ability to communicate with corporate business functions and internal business partners. • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability • Successfully work within a team/partnership environment and as an individual contributor, with a high level of professionalism • Good leadership skills and strong communication skills • Fundamental project management skills • Good analytical problem solving skills • Strong communication skills - oral and written (English and Spanish) • Organizational skills
 BS degree in Science (e.g. Biology, Chemistry, Biochemistry) and 5 years of experience in Quality area