Biotechnology Regulatory Affairs Specialist - CSC - Frederick, MD

Job Title

:

Biotechnology Regulatory Affairs Specialist

Requisition ID

:

1400124

Job Category

:

Analytic Services

Job Type

:

Regular

Primary Location

:

USA-MD: MARYLAND-FREDERICK

Schedule

:

Full-time

Remote Work Authorized

:

No

Relocation Assistance

:

Not Available

Travel

:

Yes, 10 % of the Time

Clearance Level

:

None

Employee Status

:

Regular

Job Posting

:

Jan 16, 2014, 10:48:44 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

CSC is an Equal Opportunity Employer M/F/D/V

Comments

Post a Comment

Popular posts from this blog

Protein folding via charge zippers

Jan. 18, 2013 — Membrane proteins are the "molecular machines" in biological cell envelopes. They control diverse processes, such as the transport of molecules across the lipid membrane, signal transduction, and photosynthesis. Their shape, i.e. folding of the molecules, plays a decisive role in the formation of, e.g., pores in the cell membrane. In the journal Cell, researchers of Karlsruhe Institute of Technology and the University of Cagliari are now reporting a novel charge zipper principle used by proteins to form functional units. "It is fascinating to see the elegant basic principles that are used by nature to construct molecular assemblies," explains Anne Ulrich, Director of the KIT Institute for Biological Interfaces. "A charge zipper between the charged side chains is an entirely unexpected mechanism used by membrane proteins to neutralize their charges such that they can be immersed into hydrophobic cell membranes....
Read more

Lonza: CMC Product Manager

Due to the expansion of Lonza's Analytical Services department we are looking to recruit an Analytical Product Manager. Reporting to the Group Leader you will proactively coordinate internal and external client project activities (analytical CMC development of recombinant proteins) performed within Analytical Services and to provide scientific oversight of data generated for the projects. Responsibilities:      * Primary point of contact for all analytical activities relating to product development and management of analytical development programmes from early phase development through to license application.      * Primary interface to the Program Management Team, AS study directors and internal and external customers.      * Definition, presentation and representation of analytical CMC programmes to customers, potential new customers & external meetings, including oversight of large analytical portfolio projects.      * Design an...
Read more

GlaxoSmithKline (GSK): Esprit Physician Leadership Development Programme

Esprit Physician Leadership Development Programme Are you an MBBS or MD with experience gained in a pharmaceutical, biotech or academic environment eager to become an outstanding leader? An inquisitive mind who would thrive on a diverse, intellectually demanding global leadership programme? Do you want to translate your medical expertise into disease-beating medicines? And help people across the world to do more, feel better and live longer? We are a science-led, global healthcare company that puts patients first. Our business is focused on developing medicines that improve the quality of human life. To meet the future strategic challenges this entails, we need to fast-track the finest medical talent into senior leadership roles within our business. The Esprit Physician programme is an initial three-year, accelerated, multi-disciplinary and individually tailored programme. It is heavily backed by our senior management team, and it will give you incredible standing as a phys...
Read more