Regulatory Affairs Manager/ Director (Remote)

Company: Jobot
Location: Irvine
Posted on: June 24, 2022

Job Description:

100 % RemoteThis Jobot Job is hosted by Juan CorreaAre you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.Salary $150,000 - $250,000 per yearA Bit About UsOver the years, we have observed how dramatically the microbiome can impact human health. We specialize in clinical studies that examine the mysteries of the microbiome for each individual tested. What bacteria are abundant? What bacteria are absent? What are the potential implications for overall health?Why join us?

• Competitive Base Salary!
• Full Benefits!
• Extremely Competitive Equity Package!
• Flexible Work Schedules!
• Accelerated Career Growth!Job DetailsQualifications
  • Ten + years of regulatory experience in pharmaceutical industry is required
  • Bachelor's or Master's Degree in a scientific discipline or equivalent
  • Strong written and verbal communication skills necessary
  • Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Ability to work effectively in a highly charged, fluid environment
  • Knowledge of Windows based software programs such as Word, Excel
  • Familiarity with the FDA website is important in order to accomplish daily tasksResponsibilities
    • This position is responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions
    • In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests, and supporting other departments within the organization
    • Make consistent, sound regulatory assessments of proposed changes requested by operations or R&D
    • Responsible for preparation, compilation, review and submission of new NDAs, ANDAs, DMFs and INDs in eCTD format for FDA submission
    • Write related modules (Mod 1, Mod 2 and Mod 3) in CTD format for NDA, ANDA, DMF and IND
    • The submission content, style and architecture should adhere to electronic common technical document (eCTD) format
    • Follow current FDA and ICH guidelines and current cGMP and GLPs, pharmaceutical product testing requirements
    • Refer to USP requirements for chemical, physical and microbiological testing
    • Prepare, and submit INDs, NDAs, ANDAs, DMFs and ANADA annual reports, amendments and supplements in eCTD compliant format
    • Submissions should be prepared and reviewed for accuracy, consistency, and conformance to FDA and 21CFR regulations, ICH guidelines and in-house SOPs
    • Regulatory support of post-marketing commercial activities
    • Prepare and review supplements (PASs, CBE-30 and CBEs) for FDA submission
    • Review and approve change control forms for post approval activities of the product
    • Utilize regulatory and scientific skills to evaluate changes (such as changes to an approved product)
    • Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s) and exclusivities
    • Prepare Controlled Correspondences for FDA submission based on information provided by R&D department
    • The document should be prepared by utilizing scientific rational and supporting data provided by R&D department
    • The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification
    • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this jobInterested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Irvine , Regulatory Affairs Manager/ Director (Remote), Executive , Irvine, California