Regulatory Labeling Specialist Jobs

Experience performing data entry functions a must

Work closely with the production managers to ensure and document standard operating procedures that support data quality and production efficiency

A high school diploma (an Associate degree is preferred) with a minimum of two years of related experience.

Understand transcribing procedures and relevant state-of-the-art data entry/computer equipment.

Apply regulatory standards and prepare data for output to a variety of printed and electronic media

Maintain accurate and up-to-date documentation of project details

Work in-sync with Supply Managers to meet weekly goals

Possession of excellent oral and written skills

Label machine learning data from customers

Complete tasks in a timely manner, meeting SLA deadlines

Do post-process audits and write error reports on data and tasks

Identify and resolve the root cause of low quality and provide feedback to respective teams on product improvements

10-15 years experience in Regulatory within offshore pipelines, preferably OCS

Must be ok with working in an in-office setting

Can work with minimal supervision

Must be US Citizen / US Perm Resident

Must be within a commutable distance

OCS GOM shelf permitting / pipeline permitting

Applies regulatory and technical knowledge to a wide variety of complex work assignments.

Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Knowledge of regulations and standards affecting IVDs and/or biologics

Responsible for implementing and maintaining the effectiveness of the quality system.

Supports manufacturing/operations day to day activities for change control.

Provides consultation/advice to regulatory specialist for change control and product development.

Knowledge of US regulatory reporting requirements, and financial services-related products.

10+ years of relevant experience, including 5 years of experience preparing regulatory reports.

Prior experience interacting with regulators (preferred)

Track and monitor monthly data source submissions and processing

Liaise with the Technology team to implement and test developed reporting process changes and/or investigate processing issues.

Prepare all necessary FR Y-10 Reports when reportable events occur.

Bachelor's Degree with 1 year of related experience Required

Previous experience working in a medical/pharmaceutical FDA regulated industry

Excellent written and verbal communication skills and interpersonal relationship skills

Basic knowledge of medical device documentation development activities

Knowledge of ECR and Ignite processes

Good computer skills including usage of MS Office Suite

Strong relationship management, analytical, and interpersonal skills required to quickly gain confidence of stakeholders and team members required.

Strong organizational skills enabling the management of multiple, simultaneous submissions often with different team members and different timelines.

Formal project management training optimal; practical project management skills and recent application required.

Manages communications and activities with third-party publishers and regulatory vendors.

Manages and indexes archives of regulatory submissions; manages and files regulatory correspondence.

Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred. Sophisticated MS-Office skills required.

Ensures the Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation

Quality Management System/Regulatory Compliance Program

Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research

Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance

Coordinates review, approval, and dissemination of policies with the internal compliance committee

This job does not have an education qualification requirement.

We offer opportunities for telework.

We offer opportunities for flexible work schedules.

Learn more about Federal benefits programs at: https://help.usajobs.gov/index.php/Pay_and_Benefits

Our comprehensive benefits are very generous. Our benefits package includes:

You will be evaluated for this job based on how well you meet the qualifications above.

•Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.

Reports to labeling management in Regulatory Operations and Innovation.

•Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE,, etc.).

3) STRONG TECHNICAL KNOWLEDGE OF SYSTEMS/SOFTWARE: LIFT, ALiCE, Veeva Vault, TVT,

4. Experience and/or Familiarity with Structured Content is preferred

•May be responsible for managing projects, processes, or programs with manager oversight.