COOK MYOSITE INCORPORATED, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time, Regulatory Affairs Scientist to join our team. The Regulatory Affairs Scientist will serve as a resource for interpreting and applying global regulatory requirements to the clinical to commercialization program.
Essential Job Functions/Duties
Develops regulatory strategies for products and indications within a clinical or commercial program.
Interpret global regulatory requirements and provide regulatory advice to target audiences.
Applies interpretation of regulations from clinical trial development to commercialization.
Performs regulatory review of clinical protocol and clinical trial documentation to ensure clinical activities are in compliance with global regulations.
Research regulations, guidelines, industry standards to keep up-to-date to ensure continued compliance.
Write comprehensible, user-friendly, clear product information leaflets and labels.
Assist in reviewing quality system change controls for regulatory impact and assist in writing and reviewing internal investigations.
Minimum Work Experience/Educational Requirements
M.S. degree or equivalent with 4+ years of direct regulatory affairs experience or a Ph.D. with 2+ years of relevant work experience, in biopharmaceutical industry.
Regulatory Affairs Certification (RAC) preferred.
Demonstrated pharmaceutical research experience, including working knowledge of GCP.
In-depth understanding of US and global regulatory requirements governing aspects of clinical trials.
A scientific and regulatory-based understanding of clinical practice and clinical protocol compliance.
Cook Myosite offers a handsome benefits package which includes Competitive Salary, Health/Dental/Vision Coverage, Company Paid Life Insurance, Company Paid Short Term Disability, Paid Time Off upon hire, Paid Holidays upon hire, 401(k) Eligibility upon hire, Profit Sharing, Company Incentive Bonuses, and an Educational Assistance Program.
Please note that resumes sent without a cover letter and salary requirements will not be considered.
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”