Job Description

Regulatory Labelling Specialist - Contract - Plainsboro NJ

Help bring science to life and join a leading pharmaceutical company to play a key role within regulatory affairs and help drive healthcare innovation!

Primary Responsibilities:

Proclinical is seeking a Regulatory Labeling Specialist to focus on planning and executing regulatory labeling operations, addressing potential obstacles, and creating proactive solutions. Your expertise will be crucial in ensuring efficient communication and tracking of regulatory labeling processes.

Skills & Requirements:

• Bachelor's degree in a relevant field or equivalent combination of education and experience.
• Experience in pharmaceutical, biotechnology, or related environments, focusing on labeling development and maintenance.
• Ability to work cross-functionally to develop project plans and risk mitigation strategies.
• Knowledge of process/system improvements related to labeling and product registrations (e.g., LIFT, Veeva Vaults RIM, SPL)

The Regulatory Labelling Specialist's responsibilities will be:

• Collaborate with cross-functional teams to plan and execute regulatory labeling operations.
• Anticipate and address labeling challenges, identifying emerging issues and developing solutions.
• Participate in FDA submission planning meetings to communicate project plans, action items, risks, and decisions.
• Ensure all regulatory labeling information is tracked, archived, and accessible.
• Manage project data in Regulatory Label Management systems.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at j.jones@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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