Job description

The internationally recognized University of University of Missouri Research Reactor (MURR)is a 10-megawatt nuclear research facility and the most powerful research reactor located on the Mizzou campus. MURR is a campus research center which operates under the Division of Research, Innovation & Impact.
MURR is the highest-power university research reactor in the United States, operating at 10 megawatts, 6.5 days a week and 52 weeks a year. The MURR facility enables research across many disciplines – From investigating ancient cultures and how plants respond to their environment, to analyzing industrial materials and developing radiopharmaceuticals that have lifesaving clinical applications, the MURR facility is a reliable resource for researchers, scientists, engineers and students across the country.

Job Description

In fast-paced and rapidly growing research and business environment, this position will function within a dynamic work environment where creativity and communication with employees at all levels within the organization is essential.

The ideal candidate will understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.

Key duties performed by this position will include:

The Regulatory Affairs Specialist will focus on the creation and maintenance of drug master files for multiple drug substances, with focus in US and EU human drug regulation, in particular for Active Pharmaceutical Ingredients.
The candidate will:

• Develop technical content for new or revised Drug Master File (DMF) submissions, while implementing regulatory product strategies
• Interface with counterparts at customer organizations on regulatory topics
• Work with on-the-ground production and quality teams to respond to emerging priorities
• Help MURR’s GMP programs to evolve in response to emerging regulation, guidance, and industry standards
• Lead and/or assist with customer audits and FDA regulatory inspections

In addition, the individual will:
The successful candidate will need a background in pharmaceutical regulatory affairs or quality, and the ability to partner with internal and external stakeholders in each project.

• Provide regulatory expertise as inputs to decisions affecting business contracts, customer management, quality agreements, and product development
• Provide technical expertise around the management of numerous DMF filings
• Provide recommendations and implement a solution for eCTD packaging
• Stay current on regulatory and industry expectations, including maintaining professional training
• Experience increasing levels of responsibility and opportunities for advancement within the organization

A successful candidate will communicate effectively in writing and verbally on complex technical topics, to both technical and non-technical audiences.

They will be an independent worker with exceptional organizational skills.
They must demonstrate customer service, collaboration, and integrity in dealings with coworkers, regulators, and customers.

Shift

Monday - Friday, 8:00 a.m. - 5:00 p.m

Minimum Qualifications

A Bachelor's degree or an equivalent combination of education and experience and at least 6 years of experience from which comparable knowledge and skills can be acquired is necessary.

Preferred Qualifications

Bachelors degree with a science background in Chery or Microbiology preferred.
5 years of direct experience in Regulatory Affairs.
Experience in environment regulated by US or EU human Drug Relation.

Columbia Missouri Information

Columbia, Mo., is known as an ideal college town, combining small-town comforts, community spirit and low cost of living with big-city culture, activities and resources. Home to nationally renowned public schools and other colleges and educational centers, Columbia is packed with restaurants and entertainment venues and hosts more than a dozen annual cultural festivals.

Benefit Eligibility

This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, and educational fee discounts. For additional information on University benefits, please visit the Faculty & Staff Benefits website at http://www.umsystem.edu/totalrewards/benefits

Diversity Commitment

The University of Missouri is fully committed to achieving the goal of a diverse and inclusive academic community of faculty, staff and students. We seek individuals who are committed to this goal and our core campus values of respect, responsibility, discovery and excellence.

Equal Employment Opportunity

Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, protected veteran status, or any other status protected by applicable state or federal law. This policy shall not be interpreted in such a manner as to violate the legal rights of religious organizations or the recruiting rights of military organizations associated with the Armed Forces or the Department of Homeland Security of the United States of America. For more information, call the Director of Employee and Labor Relations at 573-884-2577.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.

EEO IS THE LAW

Please apply directly through the University website directly by following this link: https://erecruit.umsystem.edu/psp/tamext/COLUM/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&SiteId=6&FOCUS=Applicant&SiteId=6&JobOpeningId=44411&PostingSeq=1

Job Type: Full-time

Pay: $75,000.00 - $124,690.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Relocation assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• On call

Work Location: One location

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