Regulatory Affairs Ops Specialist I

Job Description

Description:

• 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.
• Knowledge, skills, and/or abilities: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.
• Bachelor’s Degree or country equivalent with a minimum of 5 years in a regulated environment.
• Scientific or related discipline would be an advantage.