US-Northeast, Regulatory Labeling Manager
Company Info; Description; RequirementsJob Title: CMC Regulatory Labeling Manager
This position will have responsibility for review and approval of labeling to support the US and Canadian pre-approval and commercial efforts. This person will be liaison within GRA operations team and local regulatory filing teams. This position will be responsible for working towards improving the systems and processes for labeling change and approval. The position will work closely with the RA filing teams and project management to assure support of all ongoing product submissions.
· Manage external collaborations in a way that is in line with departmental and corporate budgets.
· Assist in timely filings and supplemental labeling change management that support efficient supply chain management to minimize materials waste.
· Provide regulatory support for ANDA, ANDS and NDA filings, specifically labeling reviews/support for approved products and pending products including assisting in all phases of labeling lifecycle maintenance.
· Maintain and coordinate SPL and assist in the coordination of FDA gateway electronic submissions.
· Maintain drug listings and establishment registrations.
· Monitor FDA’s website for RLD Updates.
· Provide regional support for global core labeling efforts.
· Interact with IPM to assure labeling is in line with the terms of patent certification and marketing authorizations.
· Work with marketing team to assure packaging configurations and branding efforts are supported and in line with regulatory requirements and good practices.
· Work with Pharmacovigilance for providing labeling information related to PADERS.
· Interact with FDA and TPD as needed to assure current guidance is accurate and resolve any issues or challenges.
· Improve systems, both electronic and paper, to support a cleaner flow of review and approval process.
· Assist in evaluation and implementation of software solutions for labeling efforts locally and globally
· Bachelor’s degree required.
· Equivalent experience will be considered
· Minimum 3 to 5 years’ pharmaceutical regulatory experience with direct labeling review experience.
· Demonstrated experience interacting with health authorities.
· Knowledge of CFR and Guidance procedures followed by FDA and TPD.
· Strong verbal and written communication skills.
· Strong working background in related computer applications.
Prior history in eCTD and SPL software and systems.
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