Our Strength Is Our People.

Passion.

Principles.

Perspective.

At Watson, these are the traits that drive our growth and we apply them to every project and product.

If you bring these qualities to your work, then we'd like you to consider joining our team.

We currently have an exciting opportunityfor a Manager, Regulatory Affairs position based in our Salt Lake City, UT facility. This position reports to the Executive Director, Proprietary Regulatory Affairs and oversees and participates in the timely preparation, revision, review, approval and submission of all labeling (labels, package inserts, and carton) for generic and branded prescription products. Other responsibilities include but are not limited to the following: • Assign/delegate generation and proofing of all labeling to staff members.

Maintain awareness of incumbent’s skill levels and degree of proficiency.

Review for accuracy as needed to confirm compliance with FDA requirements and company policies and procedures.• Prepare labeling submissions, amendments, and supplements for new and existing products.

Ensure that revised labeling is submitted to FDA in a timely manner.Communicate with site product planning departments to establish implementation dates for new labeling revisions that will minimize company losses due to destruction of obsolete inventory.• Monitor FDA labeling website to ensure that labeling is kept current with the FDA approved labeling.

Monitor available innovator websites to ensure that important warnings, precaution and adverse event information are incorporated into our labeling to provide the greatest of protection to customers.• Maintain awareness of innovator patents and exclusivity relative to company product submissions.

Initiate discussion and review of questionable sections of insert labeling with legal department for agreement on company filing strategy.• Work with printing companies and internal departments as necessary on the design and generation of labeling components to increase efficiency of packaging lines.

Combine physician and patient leaflets or multiple patient leaflets into one document where applicable to reduce number of components attached to the product container.• Interact closely with business development and marketing on new product ventures.• Maintain communication with contract manufacturers and vendors to ensure all company labeled products meet FDA requirements.

Provide assistance as necessary with labeling issues.• Provide training and coaching to increase employee knowledge, skills and development.Generate guidelines and procedures to facilitate an understanding of and compliance with departmental practices.• Ensure project deadlines and performance standards are established and met.• Ensure compliance with all Company policies and procedures, including safety rules and regulations.
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