Regulatory Affairs Associate-BC
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
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.
Our client is a development stage biotechnology company with a leadership
position in targeted protein therapeutics. Our client 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. Our client's technology is highly regarded because
it is capable of generating disease selective protein expression. They will
be the leader in targeted protein products that are safe and effective for
use in the treatment of cancer and inflammatory diseases.
Our client offers a competitive compensation package including full medical
benefits. Located in BC, minutes away from the Coastal Mountains and the
Pacific Ocean. Consistently ranked among the most attractive and livable
cities in the world,
BC offers a unique, cosmopolitan lifestyle with a distinctly international
Please submit a Curriculum Vitae and the names of three references
Please send salary expectations, resume and cover letter highlighting the
above mentioned qualifications to sdawson at bluelime.ca.
Bluelime Consulting Inc.
sdawson at bluelime.ca