The Regulatory Affairs Specialist is responsible for managing and documenting the routine regulatory activities for Ceva’s US approved and marketed pharmaceutical products to ensure applicable regulations are followed.

Complete regulatory duties for marketing of approved pharmaceutical products.

• Review and approve label changes

• Review advertising and promotional materials

• Assist with training on regulations

Complete regulatory duties for on-going compliance of approved and marketed products.

• Ensure FDA drug listings and establishment registrations are accurate and complete by Revising and submitting electronically as needed

• Perform regulatory assessments for change controls and documenting action items in the Quality database

• Prepare, review and electronically submit FDA post-approval reports such as MCSRs and DERs

• Prepare, review and electronically submit dossier supplements and label amendments as needed to support the business

• Provide regulatory support for product acquisitions and product transfers

• Submit state licensing renewals and changes while maintaining a state licensing database

Track and monitor critical regulatory deadline and milestones.

• Maintain a regulatory database for products and registration dates

• Maintain a system for documenting regulatory correspondence, tracking submissions and commitments

• Keep current with changing or new regulations and implementing new practices and procedures as needed

• Provide regulatory assistance for resolving import issues (as needed)

o Write and edit department SOPs

• Shape solutions out of complexity

• Client focus

• Collaborate with empathy

• Engage and develop

• Drive ambition and accountability

• Influence others

• History of US FDA post-approval submissions

• CMC experience is an asset

• Excellent interpersonal, written, organizational, and communication skills

• Detail oriented, firm but calm demeanor, and strategic thinker

• A self-starter with the ability to work independently

• Proficient in technical writing

• Proven ability to effectively communicate and collaborate within multi-departmental project teams (e.g. Marketing, QA, Supply Chain, Industrial, R&D)

• Ability to multi-task and adjust duties as needed

• Eager to work in a dynamic, growing and diverse international company

• Ability to network, influence, and negotiate with internal and external stakeholders for Ceva’s best interest

Education - BA/BS in a scientific discipline is preferred.

Work Experience - Basic knowledge of FDA/CVM regulations governing drug products - 21 CFR. Minimum of 2 years industry experience at an FDA-regulated facility. Demonstrated ability to learn and understand regulations and navigate through the bureaucratic processes. EPA regulatory experience (40 CFR) is a plus.

N/A

Ability to work from home up to 60% of the time.

Domestic Travel is approximately 5%.

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.