Regulatory Affairs Operations Specialist

Katalyst Healthcares & Life Sciences - Cambridge, MA (30+ days ago)


Job Description:
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.
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.

Job Requirements:
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 minimum of 5 years in a regulated environment.