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Regulatory Affairs Ops Specialist
Ref No.: 18-02821
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 07/02/2018 to 12/07/2018
Job Title: Regulatory Affairs Ops Specialist
Job Duration: 5 Months
Job Location: Cambridge, MA
  • This section focuses on the main purpose of the job in one to four sentences.
  • Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.
  • Produces and evaluates technical and scientific data necessary for regulatory submissions.
  • Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.
  • This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
  • The incumbent will perform other duties assigned.
  • Document all system related issues, and identify resolutions Document complex processes and create and manage documentation related to validated systems Participate in identifying solution to meet requirements for systems Participate in system upgrades to assure integrity of data is maintained Assure adequate access and functioning of system tools and version upgrades Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities Participate as an active team member and provide expertise to project teams as required May verify the maintenance of support systems, libraries and dictionaries Maintain awareness of regulatory requirements and evaluate potential impact to company To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • List knowledge, skills, and/or abilities required.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • Detail oriented Technical system skills (e.g. word processing, spreadsheets, databases, online research) Written and verbal communication skills Knowledge of applicable regulations Excellent organizational skills and ability to support multiple projects Ability to contribute to multiple projects from an operations perspective Work independently with minimal direct supervision Strong negotiation and collaboration skills Manage multiple projects and deadlines Ability to identify compliance risks and resolve or escalate when necessary Experience in addressing complex problems or processes Include the education and experience that is necessary to perform the job satisfactorily.
  • Bachelors Degree or country equivalent with a minimum of 5 years in a regulated environment. Scientific or related discipline would be an advantage.