We have an immediate opening for a full-time regulatory compliance specialist at our facility in south austin, texas.
***please submit your reply along with your cv/resume attached as a word doc/pdf file over here.
we are a private laboratory providing stem cell processing and storage services. This position is responsible for reading and interpreting all applicable international, federal, state and local regulations for our industry and advising senior management on recommended actions to insure compliance with those regulations. The primary regulations applied to us are cfr title 21 section 2171.10 however there are others which are also relevant.
***specific knowledge of these are not required however it would provide a large advantage over other applicants.
***general knowledge and experience with fda, cglp, cgtp, osha, iso, and other regulatory structure is required. In addition to usa fda regulatory compliance this position would help to insure our compliance with the uk human tissue authority (hta) regulations as they apply to our industry.
***a successful candidate will have the following attributes:
some biological lab experience including mammalian cell culture is preferred
quality assurance experience is required.
regulatory compliance experience require however extensive experience working in a regulated lab may substitute depending on the circumstances.
have a bs degree with 5 year of relevant experience or an advanced degree with 2 year of relevant experience.
some previous personnel management experience is desired but not required.
be familiar with reading and writing sop’s, capa’s and risk analysis.
be familiar with conducting internal regulatory audits.
***please attach your cv/resume here to apply.
***note this full-time, on-site job position does not provide visa sponsorship.+74 Other Responses
Pharma & Biotech Regulation And Compliance
We are a small private equity fund looking for corporate attorneys from "white shoe" firms who have experience engaging with clients in the pharmaceutical and/or medical device industries regarding kol compliance (as regulated by the fda, oig, and/or us doj or similar entities in other countries). Have questions about trends concerning regulation of kol engagement, particularly with regard to "anti-kickback" legislation and the need for companies to monitor and track their kol engagements and payments in particular.+undefined Other Responses
Clinical Research Regulatory Service
• study objective:
to assess the clinical research consulting space with special emphasis on independent review board (irb) services. The aim is to understand the dynamics in the service/product offerings (regulatory compliance, medical writing, strategic affairs, electronic consent manager, meeting scheduler etc.). In addition, we would also like to understand the market overview of irb services comprising of market size, recent trends, drivers, barriers, etc. Focus would be to understand the customer needs, competitive landscape, pricing and market landscape for irb consulting services (regulatory compliance, medical writing, strategic affairs etc.).
• following are some of the key questions:
o what are the different services offered under regulatory consulting in clinical research?
O who are the key users / customers of regulatory consulting services?
O what are the needs for these services of different customers
o what are the factors that influence the customer’s purchase decision of consulting services / products?
O who are the top players providing consulting services and what is their market share?
O what are the billable rates charged on an hourly basis by the companies?
O why, if at all, do the rates differ across various services?
O are there different rates for different customer types? What are the reasons?
O how is the pricing structured for software products such as electronic consent form, meeting scheduler etc.?
o what are the key market trends, growth drivers and barriers to growth etc.?
o where are the key opportunities within the regulatory consulting market?
Preferred expert should meet the following criteria:
o location: us
o industry experience of 15+ years in the clinical research industry
o worked in coordinating clinical trials, device trails and observational studies, regulatory & irb submission, recruitment, data collection and input, source documentation creation, and overseeing good clinical practices (gcp) and ich guidelines
o understanding of clinical studies to ensure compliance with ich/gcp guidelines and federal regulations
o knowledge of regulatory consulting services as well as software offerings specific to clinical trial / research
o understanding of purchase process and pricing structure of consulting services+12 Other Responses