• Support CMC change management, including change control issuing and assessments, as well as task management to ensure compliance with quality management systems.
• CMC regulatory operations (e.g., coordinate regulatory submission timelines, manage regulatory documents, prepare content plans for regulatory submissions, and maintain submission information).
• Draft, review, and manage CMC content for IND, CTA, NDA/BLA submissions and responses to regulatory authorities, with a focus on late-stage (Phase III) development and commercialization.
• Manage the preparation, review, and submission of global CMC regulatory dossiers and information request responses according to CMC regulatory strategies.
• Author, revise, and/or review technical documentation including but not limited to testing protocols, technical reports, and standard operating procedures.
• Provide technical CMC leadership in support of manufacturing operations, including on-floor presence as needed during production campaigns or investigations.
• Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans.
• Support the establishment and maintenance of infrastructure tools, procedures, and systems for CMC regulatory and CMC development.
• Keep current with global regulatory guidelines applicable to CMC. Serve as a subject matter expert on regulatory expectations related to process development, analytical methods, and control strategies, especially for peptide-based therapeutics.
• Perform other duties as assigned

Qualifications

• Exceptional organizational and project management proficiency, which highlight the capability to prioritize and handle multiple tasks concurrently.
• Ability to draft, review and format CMC module 3 sections.
• Ability to convey complex ideas in a simple manner to management and customers.
• Ability to understand and communicate scientific or technical information.
• Ability to work across multi-disciplinary groups and lead decision-making discussion.
• Excellent interpersonal, negotiation, communication, and collaborative skills.
• Demonstrated record of high productivity and results.
• Ability to travel up to 20%.

Work Environment

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• May be required to sit or stand for long periods of 8 hours a day while performing duties. 
• Willingness to complete safety training within allotted time limits, and work in a team-based environment.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.