Adecco Medical and Science is currently recruiting for a Senior Regulatory Affairs Specialist for our Pharmaceutical client in Marlborough, MA. This is 9-12 month contract with potential for extension and offering a pay rate in the $75-85/hour range. Please review the desired skills and experience below, and call Scott Shuman at 585.613.3028.
Pre or Post market duties
RA subject matter expert to lead RA team
Regulatory Intelligence and implement strategies
Ensure best practices and optimal submission of regulatory medical product clearance files & post market reports
File / Maintain regulatory deliverables
Educate, train, & advise company professionals to ensure compliance with regulatory requirements
Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions • Communicate with Product RA resources to establish regulatory requirements, including clinical trial data. • Provide RA support as needed to clinical studies to ensure regulatory requirements are met. • Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required. • Act as liaison with external regulatory reviewers to gain rapid approval of submissions. • Work with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license. • Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes. Postmarket: • Reviews new reportable adverse events • Prepare Regulatory Authority responses • Support regulatory compliance and optimization of quality system procedures
Bachelor's Degree and 3-6 years' experience (pharmaceutical or biotechnology regulatory) OR 7+ years progressive regulatory affairs experience in pharmaceutical or biotechnology industry
IND, NDA or related submission experience
Regulatory Affairs Certification (RAPS)
Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health)
Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL
Knowledge of Quality Management Systems (QMS)
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