Biotechnology Regulatory Affairs Specialist - Computer Sciences Corporation - Frederick, MD

Job Title: Biotechnology Regulatory Affairs Specialist Requisition ID: 1400124
Job Category: Sciences Primary Location: USA-MD: MARYLAND-FREDERICK Schedule: Full-time Job Type: Regular Travel: Yes, 10 % of the Time Job Posting: Jan 16, 2014, 11:48:44 AM

Description:
CSC has an immediate position for a Biotechnology Regulatory Affairs Specialist. The position is located in Frederick, Maryland

Essential Job Functions

Develop regulatory technical writing strategy to advance a product through the national and/or international regulatory approval process at all stages of biopharmaceutical product development.

Responsible for preparing regulatory applications/submissions/plans for recombinant vaccines.

Generate and review documents for FDA meetings.

Qualifications
Basic Qualifications

Bachelor's degree or equivalent combination of education and experience

Bachelor's degree in engineering, mathematics, chemistry, biology computer science, or related field preferred

Four or more years of experience in application and/or engineering technology development

Experience working with relevant scientific development and engineering principles and practices

Experience working with company products and offerings

Experience working with the technology industry

Experience working with mathematical, physical, chemical, aerodynamic or biological principles

Other Qualifications

Experience in the generation and review of submission documents, such as pre-IND, IND, IND amendments, BLAs, safety reports and technical information packages for FDA meetings is needed

Working knowledge and training of the regulatory requirements and quality issues for licensing biopharmaceuticals with experience in regulatory writing

Strong scientific background in chemistry or life sciences is preferred with applied technical experience in compliant manufacturing and testing (CGMP/GLP).

Ability to work independently and as part of a team

Organizational skills to balance and priortize work
Interpersonal skills to interact with customers and team members
Remote Work Authorized: No Relocation Assistance: Not Available Clearance Level: None

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