Title: Regulatory Affairs Ops Specialist

Pay: $37-$45.50

Type: Hybrid

Duration: 12 months

Key Responsibilities:

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.
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

Qualifications:

Bachelor's Degree or country equivalent with a minimum of 5 years in a regulated environment.
Scientific or related discipline would be an advantage.
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