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Regulatory Affairs Specialist V

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POST DATE 9/19/2016
END DATE 10/15/2016

Azzur Group Swiftwater, PA

Swiftwater, PA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description:

We're hiring! Azzur Group is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever- changing healthcare field while simultaneously and organically exuding Azzur s core values: PUTS OTHERS FIRST, HAS THE COURAGE TO TAKE ACTION, TAKES PERSONAL RESPONSIBILITY & HAS FUN! ESSENTIAL DUTIES AND RESPONSIBILITIES: Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will commensurate with the level of incoming experience. The Regulatory Specialist will be responsible to author technical documents in Company's internal documentation system. Candidate must have working knowledge of bacterial biologics and regulations pertaining to early and late phase pre-licensure activities. Also must have working knowledge of GMPs and application to preparing clinical materials. Specialist must be well-organized, work with minimal management, and meet aggressive timelines. Other duties include utilizing knowledge of word processing software, strong writing, and analytical skills to document software capabilities and functionality. EXPERIENCE AND QUALIFICATIONS:Bachelor's degree in Biology or Chemistry or in a related disciplineMinimum of 3-6 years of experience in cGMP environmentExperience with drug/biologics licensurePrior regulatory experienceStrong verbal and written skillsTechnical writing experience (CMC experience )Working knowledge of Microsoft Office Should you be interested in finding out more about this exciting opportunity and working for the Azzur Group, please contact us. Our staff enjoy challenging work, being valued by clients, gaining experience, developing industry expertise/contacts and working for a company that lives its core values. Put Others First .Have the Courage to take Action.......Take Personal Responsibility. ...Have Fun!

Company Description:

Azzur Group is a partnership of companies and talented professionals strategically unified to better serve its customers. They offer a comprehensive service line designed to help businesses throughout every step of the system life cycle. Azzur Group offers consulting services and project resources within the quality assurance, laboratory, clinical, IT/IM, business processes, manufacturing, process engineering, operations and R&D settings. Azzur Group's experienced staff can help with requirements definition, vendor selection, configuration, implementation, testing & validation, calibration, certification and maintenance.