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Director, Regulatory Affairs and Science

Employer
University of California, Los Angeles
Location
Los Angeles

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Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details



Director, Regulatory Affairs and Science
University of California, Los Angeles



Requisition Number: JPF04348
Recruitment Period Open February 14th, 2019 through March 15th, 2019 Description

The Ahmanson Division of Translational Imaging (ATID), Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA, is recruiting a non-tenure track, full-time Adjunct faculty position at the Assistant Professor level to serve as Director of Regulatory Affairs and Science. The anticipated start date is July 1, 2019.

The ATID has created a successful translational science program, ranging from biology, chemistry/radiochemistry, PET probe development, drug development, and preclinical imaging to clinical research and clinical service. Among its more recent accomplishments is the establishment of the premier translational theranostic program in the nation.

To meet the Division's distinct and growing needs, this position will be responsible for five general areas: regulatory science (including strategic planning, preapproval, approval, and postapproval), animal GLP safety pharmacology and toxicology research, biomedical cyclotron facility GMP compliance, nuclear medicine clinical GCP compliance, and teaching and training. Responsibilities include, but are not limited to, the following:

Regulatory Science

  • Strategic planning - oversee the regulatory framework, determine regulatory pathways and options, and interact with industry and other academia
  • Preapproval - oversee all aspects of nonclinical and clinical development, CMC and manufacturing, and FDA interaction
  • Approval - manage all regulatory and administrative, nonclinical and clinical, CMC and manufacturing aspects, and the submission and review process
  • Postapproval - manage postmarketing/maintenance, postmarketing surveillance/vigilance, advertising, promotion, labeling, distribution, and FDA interaction

    Animal GLP Pharmacology and Toxicology Research
  • Provide leadership and direction to the ATID for human use enabling animal safety pharmacology and toxicology research
  • Strategically plan, direct and manage GLP animal safety pharmacology study and toxicology studies
  • Negotiate and liaise with preclinical animal study Contract Research Organizations (CROs)

    Biomedical Cyclotron Facility GMP Compliance
  • Oversee and manage the planning, implementation and maintenance of the quality assurance (cGMP) program at the Biomedical Cyclotron, an FDA-registered drug manufacturing facility

    Nuclear Medicine Clinic GCP Compliance
  • Direct and manage nuclear medicine quality assurance program for Good Clinical Practice regulatory compliance

    Teaching and Training
  • Provide regulatory lectures to graduate students
  • Train nuclear medicine staff and investigators in ICH E6 GCP compliance, and fundamentals of radiopharmaceutical US regulations and regulatory pathways
  • Train biomedical cyclotron cGMP staff for radiopharmaceutical cGMP requirements and compliance, regulatory policies and procedures

    Candidates must have a degree in Regulatory Science or a related field and possession of Regulatory Affair Certification by RAPS is required. The candidate must have documented experience with Investigational New Drug Applications, New Drug Applications (NDA and ANDA), and a track record of interacting with and submitting applications to institutional ethics committees.

    Candidate must also document ability to:

    • evaluate proposed investigational products for regulatory classification (PET drug, therapeutic radiopharmaceuticals, etc) and jurisdiction;
    • monitor and assess the regulatory environment for product specific guidances, competitor products etc. to propose regulatory pathways such as 505b1 505b2 NDA, 505j ANDA with paragraph certification, exploratory, traditional, single-patient emergency, single patient non-emergency, intermediate-size population, treatment INDs;
    • evaluate US regulatory implications for non-US (mostly European) development and determine the non-US data utility in supporting US drug development and regulatory submission;
    • provide input to FDA and nuclear medicine community (SNMMI meetings, etc.) to influence regulatory environment (legislation, regulation, guidance documents); publish peer-reviewed articles to share regulatory and compliance experiences and opinions to influence regulatory environment;
    • conduct regulatory due diligence and advise head of nuclear medicine of regulatory implications and risk/benefit assessment for projects collaborated with industry or other academia;
    • develop preclinical safety, pharmacology and toxicology studies for first in human enabling studies.

    Interested applicants should submit a cover letter summarizing professional experience, a curriculum vitae, and arrange for three letters of reference to be submitted.

    The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the complete University of California nondiscrimination and affirmative action policy see: UC Nondiscrimination & Affirmative Action Policy.

    We welcome candidates whose experience in teaching, research, or community service has prepared them to contribute to our commitment to diversity and excellence.

    Job location Los Angeles, CA Requirements Document requirements
    • Curriculum Vitae - Your most recently updated C.V.
    • Cover Letter
    • Statement of Research (Optional)
    • Statement of Teaching (Optional)
    • Statement of Contributions to Diversity - Statement addressing past and/or potential contributions to diversity through research, teaching, and/or service.
      (Optional)
    • Misc / Additional (Optional)
    Reference requirements
    • 3-5 letters of reference required
    How to apply
    1. Create an ApplicantID
    2. Provide required information and documents
    3. If any, provide required reference information


    To apply, please visit: https://recruit.apo.ucla.edu/JPF04348


    The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the complete University of California nondiscrimination and affirmative action policy, see: UC Nondiscrimination & Affirmative Action Policy, https://policy.ucop.edu/doc/4000376/DiscHarassAffirmAction


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  • Organization

    Working at University of California, Los Angeles

    UCLA is a public research university located in the Westwood neighborhood of Los Angeles, California. It was founded in 1919 and is the second oldest of the ten campuses affiliated with the University of California system. UCLA offers over 300 undergraduate and graduate degree programs in a wide range of disciplines and enrolls about 26,000 undergraduate and about 12,000 graduate students from the United States and around the world every year.

    UCLA features the College of Letters and Science, seven general campus professional schools, and four professional schools for the health sciences. The UCLA College of Letters and Science has 34 academic departments and 900 faculty, and houses the majority of UCLA's 129 undergraduate majors as well as the students in the Graduate Division of Letters and Sciences. The UCLA College Honors Program is also housed in the College. The College of Letters and Science's programs are divided into five academic divisions: humanities, social sciences, life sciences, physical sciences, and the International Institute. UCLA also offers certificate programs, undergraduate degree-credit and continuing education credits for non-full-time students through its UCLA Extension education program.

    The 2010 edition of U.S. News & World Report ranked UCLA as the 24th best university in the nation and 32nd best in the world. In the 2007 edition of U.S. News and World Report, UCLA Medical Center was ranked best in the West, as well as one of the top 3 hospitals in the United States alongside Mayo Clinic, Cleveland Clinic, Massachusetts General Hospital, and Johns Hopkins Hospital. In 15 of the 16 medical specialty areas examined, UCLA Medical Center ranked in the top 20.

    The campus' location in Los Angeles makes excursions to local museums, theaters, or other entertainment venues relatively quick and easy.

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