Regulatory Affairs Labeling Associate II

About Atrium:

What you do matters. As a people-centric organization, we foster an environment of collaboration, high performance, and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team.

Client Overview:

Our client is a global pharmaceutical company looking to add a Regulatory Affairs Labeling Associate II to their team.

Salary/Hourly Rate:

$50/hr – $54/hr Depending on experience

Position Overview:

The Regulatory Affairs Labeling Associate II will support labeling activities for all regulatory submissions.  The Regulatory Affairs Labeling Associate II will ensure compliance and oversee packaging material for product launches. As a subject matter expert, the Regulatory Affairs Labeling Associate II oversees electronic reports in adherence to industry standards and formatting guidelines (e.g., Structured Product Labeling (SPL), Lot Distribution Data (LDD)).

Responsibilities of the Regulatory Affairs Labeling Associate II:

• Work cross-functionally on the planning/execution of regulatory labeling operations.
• Participate in FDA submission planning meetings.
• Ensure regulatory labeling items are tracked, archived, searchable, and accessible.
• Manage project data within the Regulatory Level Management Systems. 
• Collaborate with Regulatory Project Managers to develop labeling items aligned with project plans.

Required Experience/Skills for the Regulatory Affairs Labeling Associate II:

• The Regulatory Affairs Labeling Associate II must have experience with Structure Product Labeling (SPL).
• Must have experience with electronic comparison tools such as TVT (Text Verification Tool).
• Must have strong attention to detail for proofreading tasks. 
• Minimum of 4 years of industry experience. 

Preferred Experience/Skills for the Regulatory Affairs Labeling Associate II:

• Experience or familiarity with Structured Content.
• Project management experience.

Education Requirements:

• Bachelor’s degree is required. 

Benefits:

• Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).

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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO