Job Description

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

Job Tags

Similar Jobs

Iridium

Facilities Security Officer Job at Iridium

...What Were Looking For: Are you passionate about ensuring the Industrial Security and well-being of a company's employees, contractors, and vendors? Do you want to be part of a team committed to maintaining the highest security standards? We have an exciting opportunity...

One City Schools, Inc.

Elementary Assistant Teacher (2025-26) Job at One City Schools, Inc.

...ELEMENTARY ASSISTANT CLASSROOM TEACHER One City Schools | Madison, Wisconsin Full-Time Position | 40+ Hours per Week Posted: May 2025 JOIN OUR MISSION TO TRANSFORM EDUCATION Are you passionate about creating transformational learning experiences for young...

European Wax Center

Esthetician / Cosmetologist Job at European Wax Center

...European Wax Center's new Wilkes Barre - Arena Hub Plaza location is seeking friendly passionate licensed esthetician or cosmetology associates to join our team. Benefits: Discounts on all retail products. Great referral program. Free Body Waxing. A fun...

Stealth Communications

Senior Security Officer II Job at Stealth Communications

...Lead real-time crisis response coordination, working with federal, state, and military law enforcement agencies as required.... ...Qualifications Required: An active, transferable TS/SCI CI Poly U.S. government-issued security clearance prior to commencement. Bachelor...

Red Robin

Server Job at Red Robin

...do not have a college diploma Equal Opportunity Employer This is a tipped role and the estimate provided is based on you being paid the tip credit minimum wage plus estimated tip income. #sourcingpro #43uv #44total #redrobin251server #redrobin #gourmetventures

Regulatory Affairs Specialist Job at Swoon, Deerfield, IL

ZGE2RWVPWjVlVzNTWVJqTTRpN0JWNSt6c3c9PQ==