Perspective Therapeutics

Manager / Director – CMC Regulatory and Manufacturing Operations

Remote
Full Time
Senior Manager/Supervisor
 Reporting 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

Qualifications

To 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 Environment

The 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 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.

 
Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*