Job DescriptionJob DescriptionReporting to the Senior Director, CMC Operations, the Manager / Director, CMC Regulatory and Manufacturing Operations is a hybrid role within CMC Development supporting both regulatory and manufacturing functional areas. The incumbent is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within manufacturing operations. This role requires strong CMC regulatory experience and the ability to contribute to both hands-on technical operations and regulatory strategy for injectable products, including the drafting and reviewing of CMC content for global filings. Experience with FDA CMC submissions and peptide-based therapeutics is highly desired.

Essential Functions

• 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

QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience

Knowledge / Skills / Abilities

• 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 EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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 , , , , , , status, genetics, protected veteran status, , 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.

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