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Summary:
The Manager / Director, CMC Regulatory and Manufacturing Operations is a hybrid role at Perspective Therapeutics, supporting both regulatory and manufacturing functions. The role requires strong CMC regulatory experience, including drafting and reviewing content for global filings and contributing to both technical operations and regulatory strategy for injectable products, with a focus on peptide-based therapeutics.
Responsibilities:
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Support CMC change management, including change control issuing and assessments, as well as task management to ensure compliance with quality management systems.
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Coordinate regulatory submission timelines, manage regulatory documents, prepare content plans for regulatory submissions, and maintain submission information.
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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.
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Manage the preparation, review, and submission of global CMC regulatory dossiers and information request responses according to CMC regulatory strategies.
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Author, revise, and/or review technical documentation including but not limited to testing protocols, technical reports, and standard operating procedures.
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Provide technical CMC leadership in support of manufacturing operations, including on-floor presence as needed during production campaigns or investigations.
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Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans.
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Support the establishment and maintenance of infrastructure tools, procedures, and systems for CMC regulatory and CMC development.
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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.
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Perform other duties as assigned.
Requirements:
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Exceptional organizational and project management proficiency, which highlight the capability to prioritize and handle multiple tasks concurrently.
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Ability to draft, review and format CMC module 3 sections.
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Ability to convey complex ideas in a simple manner to management and customers.
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Ability to understand and communicate scientific or technical information.
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Ability to work across multi-disciplinary groups and lead decision-making discussions.
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Excellent interpersonal, negotiation, communication, and collaborative skills.
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Demonstrated record of high productivity and results.
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Ability to travel up to 20%.
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Must be willing to work in a facility producing radioactive materials and participate in safety programs.
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Willingness to complete safety training within allotted time limits and work in a team-based environment.
Benefits:
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Equal employment opportunities to all employees and applicants for employment.
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Prohibition of 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.
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Comprehensive equal opportunity policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
