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Manager, Regulatory Affairs Labeling

Employer
Tris Pharma
Location
Monmouth Junction, NJ
Start date
Sep 30, 2022

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Job Details

  

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. 

Our Regulatory Affairs department located in our Monmouth Junction, NJ headquarters is small but impactful. We have an immediate need for an experienced Manager, Labeling. 

This position is a hands-on role that acts as primary content expert regarding FDA labeling requirements, for producing and sending labeling submissions for ANDA/NDA applications to the FDA and for renewing annual establishment registrations. The essential responsibilities include, but are not limited to:

• Develop the overall layout, content and production design for new and revised labeling for products in eCTD format.

• Interact with internal and external business partners to ensure consistency and compliant product labeling.

• Obtain customer approval; proof print materials for final printed labeling materials for inventory production (container labels, SPL, PLR package inserts, packaging components, medication guides, REMS, brief summaries).

• Independently coordinate labeling projects, create/obtain approval/ensure implementation of new and revised labeling in accordance with applicable regulations and policies, and coordinate with outside vendors and manufacturing to ensure ordering, receipt, and implementation of new and revised labels while keeping the team appraised of progress.

• Process, prioritize, review and update label copy against documentation to ensure accuracy, independently executing technical typesetting, executes technical editing as needed for electronic files.

• Provide strategic labeling guidance regarding appropriate content consistent with FDA regulations and guidance documents.

• Ensure labeling for products marketed outside the U.S. are consistent with U.S. labeling and are organized and maintained appropriately

• Prepare and maintain official labeling files including labeling history documents.

• Prepare and review labeling sections of post-marketing reports to the FDA.

• Create/improve labeling policies and Standard Operating Procedures. 

• Maintain current establishment registrations. 

Requirements

  

QUALIFICATIONS

Associates degree (Bachelors a strong PLUS) in relevant discipline or equivalent combination of education and experience AND minimum 6 years experience in a pharmaceutical, biotechnology or FDA related environment creating and sending labeling submission to the FDA. 

· Hands on working experience with, and understanding of, FDA labeling regulations and guidance documents REQUIRED

· Current working knowledge of current Good Manufacturing Practices (cGMPs and/or Good Practices (GXP) in the pharmaceutical industry REQUIRED

· Excellent proofreading and editing skills REQUIRED

· Graphic design experience PLUS 

· People management experience PLUS

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.  #LI-DNI

Company

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body;develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large.

Find Us
Website
Phone
(732) 940-2800
Location
US Highway 130
Monmouth Junction
NJ
08852
United States
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