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LIFE SCIENCE SENIOR REGULATORY SERVICES ASSOCIATE
| Details |
Country: USA
Location: Massachusetts-Framingham/Worcester 01752
Total applied: 40
Salary/Wage:60,000.00 - 85,000.00 USD /year
Job Category:Legal
Relevant Work Experience:2+ to 5 Years
Education Level:Bachelor's Degree
Location:MA 01752
Status:Full Time, Employee
Occupations:Regulatory/Compliance Law
Career Level:Experienced (Non-Manager)
Relevant Work Experience:2+ to 5 Years
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LIFE SCIENCE SENIOR REGULATORY SERVICES ASSOCIATE
Life Science Senior Regulatory Services Associate
As industry experts in regulatory submissions (both electronic and paper), We provide technical competency with industry recognized solutions, and extensive experience to large, medium and small Life Sciences companies. We have immediate regulatory service team positions available in our Massachusetts office for experienced publishers. The candidate(s) will report directly to the Manager, Regulatory Services.
The position will be responsible for all activities required to produce and/or prepare all types (paper and electronic) of submissions. This includes:
o Document collection/inventory
o Scanning
o PDF conversion
o Bookmarking
o Hypertext linking
o Quality checking
o eCTD compilation
o Submission validation
In addition, the prospect will possess mastery in the following areas
o MS office tools
o Adobe Acrobat
o Internal/external publishing tools
o Regulatory knowledge
o ICH, US, EU, Japan, HC and ROW
o eCTD/CTD specification
The candidate will be expected to
o Possess/develop in-depth knowledge of all electronic submission regulatory guidelines, submission lifecycle & drug development
o Act as project lead (on assigned projects) when necessary
o Adhere to tight deadlines
o Create/train on internal standard operating procedures and/or work practices
o Assist with internal software development processes
o Work professionally with highly confidential information
o Demonstrate exceptional interpersonal and customer services skills
o Perform well within team environment and across all corporate levels
o Travel:
o Within Mass state, required
o Across US on special assignment as needed
Essential Qualifications:
Senior
College degree, or equivalence experience in regulatory, technical/ or scientific discipline
Minimum 2 yrs of electronic publishing experience in regulatory environment,
eCTD / CTD filing experience a plus
Salary is commensurate with experience
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