Job Title: REGULATORY ASSOCIATE
Job location: Burnaby, British Columbia
Contact:
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Saho Lindberg
Protiva Biotherapeutics Inc.
Human Resources
http://www.pleaseapply.to/protivabio
Address:
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100-3480 Gilmore Way
Burnaby British Columbia
Canada V5G 4Y1
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JOB INFORMATION
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Internet number: uve15116
The regulatory associate will be responsible for writing, organizing, tracking and maintaining
regulatory submissions to the U.S.F.D.A, including biologic INDs. The associate will
interpret regulatory guidelines and advise on compliance issues within the company by
interfacing with various departments and advising on regulatory strategy in close
collaboration with senior management and external consultants. Acts as a corporate liaison
between the company and clinicians, IRBs, IBCs, consultants, vendors and contract
research organizations. Assists the Quality Assurance leader with writing, reviewing,
implementing, and tracking standard operating procedures and deviations. Tracks projects
that relate to regulatory filings, quality assurance or clinical trial activities. May be called
upon to act as spokesperson on corporate research and development activities. Uses
professional concepts to contribute to the development of company concepts and principles
and to achieve objectives in creative and effective ways. Other duties may be assigned.
The candidate should have a Bachelor of Science degree in biosciences and 1-5 years
experience in regulatory affairs. Experience dealing with the Recombinant DNA Advisory
Committee of the NIH a plus. The candidate should also be detailed orientated, have
excellent written and oral communication skills, and demonstrate proficiency in MS Office.
Protiva Biotherapeutics is a development stage biotechnology company with a leadership
position in targeted protein therapeutics. Protiva employs a nucleic acid delivery platform
capable of delivering a variety of nucleic acids, systemically, to sites of disease. Genomics
and pharmaceutical companies with access to novel DNA sequences require effective
delivery technologies to commercialize drugs. Protiva’s technology is highly regarded
because it is capable of generating disease selective protein expression. Protiva will be the
leader in targeted protein products that are safe and effective for use in the treatment of
cancer and inflammatory diseases.
Protiva offers a competitive compensation package including full medical benefits. Located in
Vancouver, Canada, we are minutes away from the Coastal Mountains and the Pacific
Ocean. Consistently ranked among the most attractive and livable cities in the world,
Vancouver offers a unique, cosmopolitan lifestyle with a distinctly international flavor.
P lease submit a Curriculum Vitae and the names of three references to:
Protiva Human Resources
100–3480 Gilmore Way, Burnaby, BC, Canada, V5G 4Y1.
Tel: (604) 630-5061
Fax: (604) 630-5103
careers@no-spam
www.protivabio.com
Industry Information:
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- Experience: Bachelor of Science degree in biosciences and 1-5 years
Other Information:
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Languages Required:
Essential Skills Required:
General Skills:
Date Job was Posted: Jul 9, 2003
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Job Posted via Vision2Hire (http://www.vision2hire.com)
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