Regulatory Labeling Associate

The Regulatory Labeling Associate provides support to the Global Regulatory Affairs Labeling Center of Excellence (LCoE) team by supporting labeling content and artwork development activities for new products as well as updates to existing product labeling.

The Regulatory Labeling Associate will:

Master Complexity

Autonomy

• Works independently on routine tasks;

• Requires some supervision on non-routine tasks.

Managing complexity/Technical accountability

• Demonstrates technical competency to perform job function;

• Demonstrates compliance with departmental operations;

• Demonstrates knowledge of current regulations and standards.

Innovation

Continuous Learning/Managing Risk

• Demonstrates a systematic approach to solving problems.

Fueling Business Growth/Impact on Systems & Practices

• Identifies and implements improvements on work assignments.

Customer Focus

Delivery of results/Customer value

• Is proactive in fulfilling customer requirements.

Interdependent Partnering

Team Contribution

• Completes technical tasks on work teams.

Relationship skills

• Interacts effectively with peers and supervisors.

Organizational & People Development

Developing Others

• Responsible for individual development

Creating the environment

• Contributes to day-to-day harmony within the group;

• Adapts to changing priorities.

CREDO

Adheres to environmental policy and procedures and supports department environmental objectives.

 ESSENTIAL FUNCTIONS / RESPONSIBILITIES

• Assists in reviewing, analyzing, and evaluating proposed worldwide labeling including, but not limited to, packaging, instructions for use, and investigational/clinical labeling for accuracy against established standards.

• Conducting required research including part number and copy clearance verification, historical submission information, competitive labeling intelligence, etc.

• Document/artwork formatting to support copy clearance, review, and submission documentation.

• Facilitating and tracking electronic document and artwork submissions in internal systems.

• Gathering and analyzing data related to labeling processes, errors, and efficiencies and preparing associated metrics reports.

• Other activities and tasks to support the LCoE or Global Regulatory Affairs department, as assigned by management.

QUALIFICATIONS

High school diploma required, Bachelor’s degree preferred.

Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

0 years with bachelor’s degree or 3 years of prior operations, RA, QA or R&D experience preferred.

Past labeling or artwork development experience preferred.

Flexibility to work on multiple projects; ability to collect and analyze published material; familiarity with regulatory submissions, ability to develop innovative solutions to problems with limited complexity; keen attention to detail; very good organizational, communication and interpersonal skills; ability to work in a cross-functional team environment and provide quality customer service.

Familiarity/working knowledge of the following software programs (Required):

• Microsoft Outlook

• Microsoft Word

• Microsoft Excel

• Microsoft PowerPoint

• Adobe Acrobat Professional

Additional preferred software program experience includes:

• Adobe InDesign

• Adobe Illustrator

SUPERVISION / AUTHORITY

· Give no supervision to others.

· Have lead responsibilities for one or more employees.

· Responsible for work flow production, training of new employees on covered jobs, answering job-related questions in one or more areas.

· In addition, assist in reporting on performance, recommending advancements, implementing new or changed procedures. Generally recognized as Group Leader or Assistant Supervisor.

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